Uramaxin Pads

Generic Name: urea

Dosage Form: topical cloth
Uramaxin (45% Urea) Pads

For external use only. Not for ophthalmic use.

DESCRIPTION: Uramaxin® (45% Urea) Pads contain a 45% solution of urea on a textured cloth. Each gram of medicated solution contains 45% urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water.


Urea is a diamide of carbonic acid with the following chemical structure:

CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix, which results in loosening of the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas.

PHARMACOKINETICS: The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USES: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes.

PRECAUTIONS: This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Uramaxin® (45% Urea) Pads should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Uramaxin® (45% Urea) Pads is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE

REACH OF CHILDREN.

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

DOSAGE AND ADMINISTRATION: Gently apply Uramaxin® (45% Urea) Pad to affected area(s) twice daily, or as directed by a physician. After application, discard pad. Do not flush.

HOW SUPPLIED:Uramaxin® (45% Urea) Pads NDC 43538-260-45, are supplied in a carton containing 45 foil pouches, each with a single-use medicated cloth (15 g each).

Store at controlled room temperature 15°-30° C (59°-86° F).


Protect from freezing.

Manufactured for:


MEDIMETRIKS PHARMACEUTICALS, INC.


363 Route 46 West

Fairfield, NJ 07004-2402 USA


www.medimetriks.com



Manufactured by:

Groupe PARIMA, Inc.

Montreal, QC H4S 1X6 CANADA

URAMAXIN  PADS urea  cloth

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-260 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 450 mg  in 1 g

Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC)   EDETATE DISODIUM   EUCALYPTUS OIL   HYDROXYETHYL CELLULOSE (4000 CPS AT 1%)   LEVOMENTHOL   PROPYLENE GLYCOL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43538-260-45 45 POUCH In 1 CARTON contains a POUCH 1 15 g In 1 POUCH This package is contained within the CARTON (43538-260-45)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/07/2010

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)

Registrant - Groupe PARIMA, Inc. (252437850)

Establishment
Name	Address	ID/FEI	Operations
Groupe PARIMA, Inc.		252437850	manufacture

Revised: 10/2010Medimetriks Pharmaceuticals, Inc.

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Urea Lotion

Dosage Form: lotion
Urea Cream, 40% Urea Lotion, 40% Urea Gel, 40%

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Rx Only

Urea Lotion Description

Urea, 40% is a keratolytic emollient which is gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea Cream, 40% and Urea Lotion, 40% contains 40% urea, carbomer 940, cetyl alcohol, glyceryl monostearate, mineral oil, propylene glycol, purified water, trolamine, white petrolatum, and xanthan gum. Each gram of Urea Gel, 40% contains 40% urea, edetate disodium dihydrate, glycerin, hydroxethylcellulose, PEG-6 caprylic/capric glyceride, purified water, and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure:

Urea Lotion - Clinical Pharmacology

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

Pharmacokinetics – 

The mechanism of action of topically applied urea is not yet known.

Indications and Usage for Urea Lotion

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

Contraindications

Known hypersensitivity to any of the listed ingredients.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

Pregnancy:

Pregnancy category C

Animal reproduction studies have not been conducted with urea 40%. It also is not known whether urea 40% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urea 40% should be given to a pregnant woman only if clearly needed.

Nursing Mothers -

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea 40% is administered to a nursing woman.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

Urea Lotion Dosage and Administration

Apply Urea 40% to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day, or as directed by a physician.

How is Urea Lotion Supplied

Urea Cream, 40% is available as follows:

28.35 g tube (NDC 45802-170-03)

85 g tube (NDC 45802-170-53)

198.6 g tube (NDC 45802-170-77)

Urea Lotion, 40% is available as follows:

8 FL OZ (236.6 mL) bottle (NDC 45802-176-55)

Urea Gel, 40% is available as follows:

0.5 FL OZ (15 mL) bottle (NDC 45802-171-56)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

MANUFACTURED BY

PERRIGO

BRONX, NY 10457

Rev 09/09

43300 RC J2

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Urea Lotion, 40%

For External Use Only.

Not for Ophthalmic Use.

Rx Only

Urea Lotion, 40% Carton

UREA  urea  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-176 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 40 g  in 100 mL

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C   CETYL ALCOHOL   GLYCERYL MONOSTEARATE   MINERAL OIL   PROPYLENE GLYCOL   WATER   TROLAMINE   PETROLATUM   XANTHAN GUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45802-176-55 1 BOTTLE In 1 CARTON contains a BOTTLE 1 236.6 mL In 1 BOTTLE This package is contained within the CARTON (45802-176-55)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/04/2010

Labeler - Perrigo New York Inc (078846912)

Registrant - L Perrigo Compnay (006013346)

Establishment
Name	Address	ID/FEI	Operations
Perrigo New York Inc		078846912	MANUFACTURE

Revised: 08/2011Perrigo New York Inc

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Urea Cloths

Pronunciation: ue-REE-a
Generic Name: Urea
Brand Name: Kerol Redi Cloths

Urea Cloths are used for:

Treating dry, rough, scaly skin caused by certain conditions (eg, dermatitis, psoriasis, eczema, corns, calluses). It may also be used for certain other skin conditions as determined by your doctor.

Urea Cloths are a debriding agent. It works by helping the breakdown of dead skin, which helps to loosen and shed hard and scaly skin. It also softens and moisturizes the skin.

Do NOT use Urea Cloths if:

• you are allergic to any ingredient in Urea Cloths

Contact your doctor or health care provider right away if any of these apply to you.

Before using Urea Cloths:

Some medical conditions may interact with Urea Cloths. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if the affected area is broken or severely irritated

Some MEDICINES MAY INTERACT with Urea Cloths. Because little, if any, of Urea Cloths are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Urea Cloths may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Urea Cloths:

Use Urea Cloths as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands immediately before and after using Urea Cloths unless your hands are part of the treated area.


• Gently apply Urea Cloths to the affected skin as directed by your doctor.


• If you miss a dose of Urea Cloths and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Urea Cloths.

Important safety information:

• Urea Cloths are for external use only. Do not get it in your eyes, nose, mouth, or on your lips. If you get Urea Cloths in your eyes, rinse them right away with cool water.


• Do not apply to broken or severely irritated skin.


• Do not use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not use Urea Cloths for other skin conditions at a later time.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Urea Cloths while you are pregnant. It is not known if Urea Cloths are found in breast milk. If you are or will be breast-feeding while you use Urea Cloths, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Urea Cloths:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary burning, itching, irritation, or stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); redness; severe or persistent burning or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Urea Cloths:

Store Urea Cloths at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Store away from heat, moisture, and light. Keep Urea Cloths out of the reach of children and away from pets.

General information:

• If you have any questions about Urea Cloths, please talk with your doctor, pharmacist, or other health care provider.


• Urea Cloths are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Urea Cloths. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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• Urea Nail Gel Prescribing Information (FDA)


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ulipristal acetate

ue-li-PRIS-tal AS-e-tate

Commonly used brand name(s)

In the U.S.

• Ella

Available Dosage Forms:

• Tablet

Therapeutic Class: Contraceptive

Uses For ulipristal acetate

Ulipristal is an emergency contraceptive that is used to prevent pregnancy after unprotected sex or after failure of another birth control method. It works by preventing or delaying the release of a woman's egg from the ovary (ovulation). It may also prevent the attachment of the woman's egg to the wall of the uterus (womb).

ulipristal acetate should not be used as a regular birth control method. Discuss your options for birth control with your doctor.

ulipristal acetate is available only with your doctor's prescription.

Before Using ulipristal acetate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ulipristal acetate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ulipristal acetate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ulipristal in teenage females. ulipristal acetate may be used as an emergency contraceptive in teenage females but is not recommended before the start of menstruation.

Geriatric

Ulipristal should not be used in postmenopausal women.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of ulipristal acetate

To make using emergency contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

ulipristal acetate comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Use ulipristal acetate exactly as directed by your doctor. ulipristal acetate is for occasional use as an emergency birth control. It should not replace your regular birth control method. You may use ulipristal acetate at any time during your monthly period, but do not use ulipristal acetate more than one time in the same monthly period.

You may take ulipristal acetate with or without food.

If you vomit within 3 hours of taking ulipristal acetate, call your doctor right away. Your doctor may prescribe another tablet for you.

Dosing

The dose of ulipristal acetate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ulipristal acetate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For emergency contraception:
    
    • Adults—One tablet as soon as possible within 5 days (120 hours) after unprotected sex or after failure of another birth control method.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using ulipristal acetate

It is very important that your doctor check you closely to make sure ulipristal acetate is working properly and does not cause unwanted effects.

Although you are using ulipristal acetate to prevent pregnancy, you should know that using ulipristal acetate while you are pregnant could harm the unborn baby. Your doctor may give you a pregnancy test before you start using ulipristal acetate to make sure you are not pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

ulipristal acetate is not recommended in breastfeeding women.

Call your doctor right away if you have severe lower abdominal or stomach pain 3 to 5 weeks after taking ulipristal acetate. You may have a pregnancy outside of the uterus (womb), which is called an ectopic pregnancy. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

ulipristal acetate may make your next monthly period earlier or later than expected by a few days. If your next period after taking ulipristal acetate is more than 1 week late, check with your doctor right away for a pregnancy test.

Your regular birth control method such as birth control pills or patch may not work as well while you are using ulipristal acetate. After using ulipristal acetate, you must use two forms of birth control. Use birth control pills or patch together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly, during any other times that you have sex in the same monthly period you used ulipristal acetate.

ulipristal acetate may not work as well in women with a body mass index (BMI) of more than 66 pounds per square meter.

ulipristal acetate will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

ulipristal acetate Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Cramps


• heavy bleeding


• pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• headache


• nausea


• unusual tiredness or weakness

Less common

• Dizziness

Incidence not known

• Blemishes on the skin


• pimples

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: ulipristal acetate side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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Ulipristal

Pronunciation: UE-li-PRIS-tal
Generic Name: Ulipristal
Brand Name: ella

Ulipristal is used for:

Preventing pregnancy after unprotected sexual intercourse or known or suspected birth control failure.

Ulipristal is a progesterone agonist/antagonist. Exactly how it works is not known. It may prevent pregnancy by stopping or delaying ovulation or altering the lining of the uterus to prevent implantation should fertilization occur.

Do NOT use Ulipristal if:

• you are allergic to any ingredient in Ulipristal


• you are or suspect that you are pregnant


• you have already taken Ulipristal during your current menstrual cycle


• you have been through menopause

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ulipristal:

Some medical conditions may interact with Ulipristal. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of ectopic pregnancy (pregnancy outside of uterus), or you have not had your first menstrual period


• if you are overweight

Some MEDICINES MAY INTERACT with Ulipristal. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, itraconazole, ketoconazole) because they may increase the risk of Ulipristal's side effects


• Barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, efavirenz, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, primidone, rifamycins (eg, rifabutin, rifampin, rifapentine), St. John's wort, or topiramate because they may decrease Ulipristal's effectiveness


• Hormonal contraceptives (eg, birth control pills) because their effectiveness may be decreased by Ulipristal

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ulipristal may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ulipristal:

Use Ulipristal as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Ulipristal. Talk to your pharmacist if you have questions about this information.


• Take Ulipristal by mouth with or without food.


• Keep Ulipristal in its original packaging until you are ready to take it. Do not take it if the package is torn or broken.


• Take Ulipristal as soon as possible after known or suspected birth control failure or after you have unprotected sexual intercourse. The dose must be taken within 120 hours (5 days), or as directed by your doctor.


• Ulipristal can be used any time during the menstrual cycle.


• If vomiting occurs within 3 hours after taking Ulipristal, talk with your health care provider to discuss whether to repeat that dose.


• If you are unsure about your general health or pregnancy status, a follow-up physical or pelvic exam may be needed after taking Ulipristal.


• If you miss a dose of Ulipristal, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Ulipristal.

Important safety information:

• Ulipristal may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Ulipristal with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Ulipristal is an emergency contraceptive. It should not be used for routine birth control. Ulipristal may reduce the effectiveness of hormonal contraceptives (eg, birth control pills). If you have sexual intercourse after you take Ulipristal but before you have your next menstrual period, be sure to use an effective form of contraception, such as a diaphragm or condom.


• You should not take Ulipristal more than once within the same menstrual cycle; safety and effectiveness with repeated use within the same menstrual cycle have not been confirmed. Contact your doctor if you have questions about this information.


• Seek immediate medical attention if you experience severe lower stomach pain about 3-5 weeks after you take Ulipristal. This may be a symptom of an ectopic pregnancy (pregnancy outside of the uterus).


• Ulipristal may affect your normal menstrual cycle. Contact your doctor if your menstrual period is delayed for longer than 7 days after you expected it to occur.


• Ulipristal does not protect against HIV infection and other sexually transmitted diseases.


• Before you take Ulipristal, a pregnancy test may be performed. It is important to determine that you are not pregnant before you take Ulipristal. Discuss any questions or concerns with your doctor.


• Ulipristal should not be used in CHILDREN younger than 18 years old who have not started having a menstrual cycle; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Ulipristal will not end an existing pregnancy. Do not use Ulipristal if you are pregnant. If you find out you are pregnant after taking Ulipristal, contact your doctor. You will need to discuss the risks of using Ulipristal while you are pregnant. It is not known if Ulipristal is found in breast milk. Do not breast-feed while taking Ulipristal.

Possible side effects of Ulipristal:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; changes in menstrual flow or duration; dizziness; headache; nausea; stomach pain; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); lower stomach pain; missed menstrual period; pain during menstrual period; spotting instead of your usual period.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ulipristal side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ulipristal:

Store Ulipristal between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ulipristal out of the reach of children and away from pets.

General information:

• If you have any questions about Ulipristal, please talk with your doctor, pharmacist, or other health care provider.


• Ulipristal is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ulipristal. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ulipristal resources

• Ulipristal Side Effects (in more detail)
• Ulipristal Dosage
• Ulipristal Use in Pregnancy & Breastfeeding
• Ulipristal Drug Interactions
• Ulipristal Support Group
• 1 Review for Ulipristal - Add your own review/rating

• ulipristal Advanced Consumer (Micromedex) - Includes Dosage Information


• Ella Prescribing Information (FDA)


• ella Monograph (AHFS DI)


• ella Consumer Overview

Compare Ulipristal with other medications

• Birth Control
• Emergency Contraception
• Uterine Fibroids

Urea Topical Suspension

Pronunciation: ue-REE-a/SOE-dee-um HYE-al-ure ON-ate
Generic Name: Urea
Brand Name: Umecta PD

Urea Topical Suspension is used for:

Promoting the healing of certain skin conditions (eg, hyperkeratotic conditions). It may also be used for certain other skin conditions (eg, corns; calluses; rough, dry skin) as determined by your doctor.

Urea Topical Suspension contains a debriding agent and an emollient. The debriding agent works by helping the breakdown of dead skin and pus, which helps to loosen and shed hard and scaly skin. The emollient moisturizes and softens the skin.

Do NOT use Urea Topical Suspension if:

• you are allergic to any ingredient in Urea Topical Suspension

Contact your doctor or health care provider right away if any of these apply to you.

Before using Urea Topical Suspension:

Some medical conditions may interact with Urea Topical Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Urea Topical Suspension. Because little, if any, of Urea Topical Suspension is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Urea Topical Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Urea Topical Suspension:

Use Urea Topical Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Urea Topical Suspension is for external use only.


• Wash hands before and after using Urea Topical Suspension, unless your hands are part of the treated area.


• Shake well before each use.


• Apply a small amount of Urea Topical Suspension to the affected area as directed by your doctor. Gently rub in until it is evenly distributed.


• If you get Urea Topical Suspension on any skin that is not part of the treated area, wash it off thoroughly.


• You may cover the affected area unless directed otherwise by your doctor.


• If you miss a dose of Urea Topical Suspension, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Urea Topical Suspension.

Important safety information:

• Urea Topical Suspension is for external use only. Do not get it in your eyes, nose, or mouth. If you get Urea Topical Suspension in your eyes, rinse them immediately with a generous amount of cool water.


• Do not apply to broken or severely irritated skin.


• Do not exceed the recommended dose, use Urea Topical Suspension for longer than prescribed, or use Urea Topical Suspension for other skin conditions without checking with your doctor.


• Urea Topical Suspension may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Urea Topical Suspension, contact your doctor. You will need to discuss the benefits and risks of using Urea Topical Suspension during pregnancy. It is not known if Urea Topical Suspension is found in breast milk after topical use. If you are or will be breast-feeding while you use Urea Topical Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Urea Topical Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild skin irritation; temporary burning, stinging, or itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); redness; severe or persistent irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Urea Topical Suspension:

Store Urea Topical Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Protect from freezing. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Urea Topical Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Urea Topical Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Urea Topical Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Urea Topical Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Urea resources

• Urea Use in Pregnancy & Breastfeeding
• Urea Support Group
• 9 Reviews for Urea - Add your own review/rating

Compare Urea with other medications

• Dermatological Disorders
• Dry Skin
• Pityriasis rubra pilaris

Unisom Sleepgels Maximum Strength

Generic Name: diphenhydramine (DYE fen HYE dra meen)

Brand Names: Aler-Tab, Allergy, Allermax, Altaryl, Benadryl Allergy, Benadryl DF, Benadryl Dye Free Allergy, Benadryl Ultratab, Children's Allergy, Diphen Cough, Diphenhist, Dytuss, PediaCare Children's Allergy, Q-Dryl, Q-Dryl A/F, Siladryl, Siladryl Allergy, Silphen Cough, Simply Sleep, Sleep-ettes, Sleep-ettes D, Sominex Maximum Strength Caplet, Theraflu Thin Strips Multi Symptom, Triaminic Thin Strips Cough & Runny Nose, Unisom Sleepgels Maximum Strength, Valu-Dryl

What is Unisom Sleepgels Maximum Strength (diphenhydramine)?

Diphenhydramine is an antihistamine. Diphenhydramine blocks the effects of the naturally occurring chemical histamine in the body.

Diphenhydramine is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Diphenhydramine is also used to suppress coughs, to treat motion sickness, to induce sleep, and to treat mild forms of Parkinson's disease.

Diphenhydramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Unisom Sleepgels Maximum Strength (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

What should I discuss with my healthcare provider before taking Unisom Sleepgels Maximum Strength (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  an enlarged prostate, bladder problems or difficulty urinating;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  hypertension or any type of heart problems; or

  
  


• 
  

  asthma.

  
  

You may not be able to take diphenhydramine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Diphenhydramine is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take diphenhydramine without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of antihistamines, and side effects could occur in a breast-feeding baby. Do not take diphenhydramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine. You may require a lower dose of this medication.

How should I take Unisom Sleepgels Maximum Strength (diphenhydramine)?

Take diphenhydramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Diphenhydramine can be taken with or without food.

For motion sickness, a dose is usually taken 30 minutes before motion, then with meals and at bedtime for the duration of exposure.

As a sleep aid, diphenhydramine should be taken approximately 30 minutes before bedtime.

To ensure that you get a correct dose, measure the liquid forms of diphenhydramine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The maximum amount of diphenhydramine that you should take in any 24-hour period is 300 mg.

Store diphenhydramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking Unisom Sleepgels Maximum Strength (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

Unisom Sleepgels Maximum Strength (diphenhydramine) side effects

Stop taking diphenhydramine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine and talk to your doctor if you experience

• 
  

  sleepiness, fatigue, or dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Unisom Sleepgels Maximum Strength (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These products may contain medicines similar to diphenhydramine, which could lead to an antihistamine overdose.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• 
  

  anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

  
  


• 
  

  medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or

  
  


• 
  

  any other medications that make you feel drowsy, sleepy, or relaxed.

  
  

Drugs other than those listed here may also interact with diphenhydramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Unisom Sleepgels Maximum Strength resources

• Unisom Sleepgels Maximum Strength Side Effects (in more detail)
• Unisom Sleepgels Maximum Strength Use in Pregnancy & Breastfeeding
• Unisom Sleepgels Maximum Strength Drug Interactions
• 5 Reviews for Unisom Sleepgels Maximum Strength - Add your own review/rating

• Banophen MedFacts Consumer Leaflet (Wolters Kluwer)


• Ben-Tann Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Benadryl Consumer Overview


• Benadryl Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Benadryl Allergy Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Children's Allergy Prescribing Information (FDA)


• Diphen Advanced Consumer (Micromedex) - Includes Dosage Information


• Diphenhydramine MedFacts Consumer Leaflet (Wolters Kluwer)


• Diphenhydramine Prescribing Information (FDA)


• Diphenhydramine Hydrochloride Monograph (AHFS DI)


• Diphenoxylate Hydrochloride Monograph (AHFS DI)


• Dytuss Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Simply Sleep MedFacts Consumer Leaflet (Wolters Kluwer)


• Sominex MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Unisom Sleepgels Maximum Strength with other medications

• Insomnia

Where can I get more information?

• Your pharmacist can provide more information about diphenhydramine.

See also: Unisom Sleepgels Maximum Strength side effects (in more detail)