Label: IBUPROFEN DYE-FREE- ibuprofen tablet, film coated
- NDC Code(s): 49035-438-12, 49035-438-90
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 21, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each white tablet)
- Purpose
- Uses
-
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- blisters
- skin reddening
- asthma (wheezing)
- facial swelling
- shock
- hives
- rash
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 other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- take a blood thinning (anticoagulant) or steroid drug
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- are age 60 or older
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you have problems or serious side effects from taking pain relievers or fever reducers
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
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
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- have stomach pain that does not get better
- vomit blood
- you have symptoms of heart problems or stroke:
- chest pain
- slurred speech
- leg swelling
- trouble breathing
- weakness in one part or side of body
- pain gets worse or lasts more than 10 days
- any new symptoms appear
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
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Directions
- 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 pain 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
- Inactive ingredients
- Questions or comments?
-
Principal display panel
NDC 49035-438-90
equate™
Compare
to Advil®
Tablets active
ingredient†DYE FREE
Ibuprofen
Tablets USP, 200 mgPain Reliever/
Fever Reducer
(NSAID)Actual Size
100
TABLETSTAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSINGDISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF CHINA, INDIA AND UNITED STATES
†This product is not manufactured or distributed by PF Consumer Healthcare 1 LLC,
owner of the registered trademark Advil® Tablets. 50844 REV1221C43812
Equate 44-438
-
INGREDIENTS AND APPEARANCE
IBUPROFEN DYE-FREE
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-438 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TRIACETIN (UNII: XHX3C3X673) 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:49035-438-90 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/11/2004 2 NDC:49035-438-12 1 in 1 CARTON 03/11/2004 05/16/2021 2 100 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 - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(49035-438) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(49035-438) , pack(49035-438) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(49035-438) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(49035-438) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(49035-438)