Label: DYE FREE IBUPROFEN- ibuprofen tablet
- NDC Code(s): 0363-0438-12, 0363-0438-15
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 14, 2015
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- Active ingredient (in each white tablet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
Pain reliever/fever reducerClose
- temporarily relieves minor aches and pains due to:
- menstrual cramps
- the common cold
- muscular aches
- minor pains of arthritis
- temporarily reduces fever
- temporarily relieves minor aches and pains due to:
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
- facial swelling
- asthma (wheezing)
- skin reddening
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:
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- 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
- right before or after heart surgery
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
Ask a doctor before use if
- you have asthma
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- 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.
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
- if pains or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
- Other information
- store between 20º-25ºC (68º-77ºF)
- avoid excessive heat 40ºC (104ºF)
- see end flap for expiration and lot number
- Inactive ingredients
corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetinClose
- Questions or comments?
Call 1-800-426-9391 8:30 AM - 4:00 PM ET, Monday-FridayClose
- Principal Display Panel
WALGREENS PHARMACIST RECOMMENDEDǂ
USP 200 mg / Pain Reliever /
Fever Reducer (NSAID)
Compare to Motrin® IB Tablets active ingredientǂǂ
ǂWalgreens Pharmacist Survey Study, November 2010.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Motrin® IB Tablets.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreen.com ©2012 Walgreen Co.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- INGREDIENTS AND APPEARANCE
DYE FREE IBUPROFEN
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0438 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) TRIACETIN (UNII: XHX3C3X673) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;438 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0438-12 1 in 1 CARTON 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-0438-15 1 in 1 CARTON 2 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075139 03/11/2004 Labeler - WALGREEN CO. (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-0438) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0363-0438)