CARE ONE IBUPROFEN - ibuprofen tablet, coated 
American Sales Company

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American Sales Company 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)
• see end panel for lot number and expiration date {FOR USE WITH CONFIGURATIONS CONTAINING CARTON PACKAGING ONLY}

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxides, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Advil®

Effective Pain Medicine

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

Coated Caplets

See New Warnings Information

**Capsule-Shaped Tablets

CARE ONE IBUPROFEN  ibuprofen   tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 41520-647 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 COLLOIDAL SILICON DIOXIDE   STARCH, CORN   CROSCARMELLOSE SODIUM   HYPROMELLOSES   FERRIC OXIDE RED   FERRIC OXIDE YELLOW   CELLULOSE, MICROCRYSTALLINE   STEARIC ACID   TITANIUM DIOXIDE   POLYETHYLENE GLYCOL   POLYSORBATE 80

Product Characteristics Color BROWN Score no score Shape CAPSULE Size 15mm Flavor Imprint Code I;2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 41520-647-71 1 BOTTLE In 1 CARTON contains a BOTTLE 1 50 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-647-71) 2 41520-647-78 1 BOTTLE In 1 CARTON contains a BOTTLE 2 100 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-647-78) 3 41520-647-85 1 BOTTLE In 1 CARTON contains a BOTTLE 3 250 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-647-85) 4 41520-647-90 500 TABLET In 1 BOTTLE None 5 41520-647-76 1 BOTTLE In 1 CARTON contains a BOTTLE 5 120 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-647-76)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072096	04/13/2004

Labeler - American Sales Company (809183973)

Revised: 06/2009American Sales Company