Topcare Ibuprofen

Generic Name: ibuprofen

Dosage Form: tablet, film coated
Topco Ibuprofen Tablets 200 mg Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:


• headache


• muscular aches


• minor pain of arthritis


• toothache


• backache


• the common cold


• menstrual cramps


• temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives


• facial swelling


• asthma (wheezing)


• shock


• skin reddening


• rash


• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chances are higher if you

• are age 60 or older


• have had stomach ulcers or bleeding problems


• take a blood thinning (anticoagulant) or steroid drug


• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]


• have 3 or more alcoholic drinks every day while using this product


• take more or for a longer time than directed

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer


• right before or after heart surgery

Ask a doctor before use if

• you have problems or serious side effects from taking pain relievers or fever reducers


• the stomach bleeding warning applies to you


• you have a history of stomach problems, such as heartburn


• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease


• you have asthma


• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin


• under a doctor’s care for any serious condition


• taking any other drug

When using this product

• take with food or milk if stomach upset occurs


• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding:


• feel faint


• vomit blood


• have bloody or black stools


• have stomach pain that does not get better


• pain gets worse or lasts more than 10 days


• fever gets worse or lasts more than 3 days


• redness or swelling is present in the painful area


• any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• do not take more than directed


• the smallest effective dose should be used


• do not take longer than 10 days, unless directed by a doctor (see Warnings)

Adults and children 12 years and older:

• take 1 caplet every 4 to 6 hours while symptoms persist


• if pain or fever does not respond to 1 caplet, 2 caplets may be used


• do not exceed 6 caplets in 24 hours, unless directed by a doctor

Children under 12 years: ask a doctor

Other information

• read all warnings and directions before use


• store at 20-25°C (68-77°F)


• avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40, FD&C yellow no. 6, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions or comments?

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Caplets

Ibuprofen Tablets 200 mg

Pain Reliever/Fever Reducer (NSAID)

This Package For Households Without Young Children

Actual Size

Compare to Motrin® IB active ingredient

†Capsule-Shaped Tablets

Ibuprofen Tablets 200 mg Label

Topcare Ibuprofen  ibuprofen  tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-183 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 15mm Flavor Imprint Code I2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-183-83 225 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077349	04/22/1993

Labeler - Topco Associates LLC (006935977)

Revised: 04/2010Topco Associates LLC

More Topcare Ibuprofen resources

• Topcare Ibuprofen Side Effects (in more detail)
• Topcare Ibuprofen Use in Pregnancy & Breastfeeding
• Drug Images
• Topcare Ibuprofen Drug Interactions
• Topcare Ibuprofen Support Group
• 51 Reviews for Topcare Ibuprofen - Add your own review/rating

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