DYE FREE IBUPROFEN- ibuprofen tablet, film coated
Dye Free Ibuprofen by
Drug Labeling and Warnings
Dye Free Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredient (in each white tablet)
- Purpose
- Uses
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- rash
- facial swelling
- asthma (wheezing)
- hives
- skin reddening
- shock
- 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:
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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
- 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
- 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, kidney disease, asthma, or had a stroke
- 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
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
- 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
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
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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
Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂNDC: 0363-0438-99
Dye-Free
Ibuprofen
Ibuprofen Tablets USP, 200 mg /
Pain Reliever / Fever Reducer (NSAID)100 TABLETS
DYE
FREECompare to Advil® Tablets
active ingredientǂǂTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING‡ Walgreens Pharmacist Survey Study, November 2016.
‡‡ This product is not manufactured or distributed by
Wyeth Consumer Healthcare, owner of the registered
trademark Advil® Tablets.
50844 REV1116C43812DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2017 Walgreen Co.
Walgreens 44-438
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INGREDIENTS AND APPEARANCE
DYE FREE IBUPROFEN
ibuprofen tablet, film coatedProduct 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TRIACETIN (UNII: XHX3C3X673) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 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 03/01/1999 04/07/2019 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC: 0363-0438-15 1 in 1 CARTON 03/01/1999 10/08/2016 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC: 0363-0438-99 1 in 1 CARTON 03/01/1999 08/02/2021 3 100 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 03/01/1999 08/02/2021 Labeler - Walgreen Company (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) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(0363-0438) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(0363-0438) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(0363-0438)
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