IBUPROFEN- ibuprofen tablet, film coated 
WALGREEN CO.

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Active ingredient(s)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Use(s)

  • temporarily relieves minor aches and pains due to:

  • headache

  • toothache

  • backache

  • menstrual cramps

  • the common cold

  • muscular aches

  • minor pain of arthritis

  • 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 chance is 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

  • stomach bleeding warning applies to you

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

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

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

  • you are taking a diuretic

  • you have asthma

Ask a doctor or pharmacist before use if

  • under a doctor"s care for any serious condition

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

  • 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

  • have bloody or black stools

  • vomit blood

  • 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.

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 over: 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

  • store between 20°-25°C (68°-77°F)

  • avoid excessive heat 40°C (104°F)

  • see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday 8:30 AM-4:00 PM ET, Monday-Friday

Product Packaging

 Walgreens

NDC 0363-0292-12

Compare to Advil® Caplets

active ingredient

IBUPROFEN

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

SEE NEW WARNINGS INFORMATION

100 CAPLETS**

**(Capsule-shaped tablets)

CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844       REV0910M29212

Distributed by: Walgreen Co.,

200 Wilmot Rd., Deerfield, IL 60015-4616

Product Packaging



IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0292
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code 44;292
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0292-121 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
2NDC:0363-0292-151 in 1 CARTON
250 in 1 BOTTLE, PLASTIC
3NDC:0363-0292-14500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501005/24/1988
Labeler - WALGREEN CO. (008965063)

Revised: 05/2011
 
WALGREEN CO.