IBUPROFEN tablet, film coated
Ibuprofen by
Drug Labeling and Warnings
Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- 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:
- skin reddening
- rash
- facial swelling
- asthma (wheezing)
- hives
- 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 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]
- take more or for a longer time than directed
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
- 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?
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Principal Display Panel
MAJOR®
NDC: 0904-7914-51
Compare to the active ingredient
in Motrin® IB Tablets†IBU-200
Ibuprofen Tablets USP, 200 mg
PAIN RELIEVER
FEVER REDUCER (NSAID)50 Tablets
Dye-Free Film Coated TabletsTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING†This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Motrin® IB Tablets. 50844 REV0418B43815Distributed by: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152 USA M-17 Rev. 07/18
Re-order No. 700808
44-438
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0904-7914 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 STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TRIACETIN (UNII: XHX3C3X673) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) 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: 0904-7914-61 10 in 1 CARTON 03/01/1999 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC: 0904-7914-59 1 in 1 CARTON 03/01/1999 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC: 0904-7914-51 1 in 1 CARTON 03/01/1999 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC: 0904-7914-80 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/1999 11/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075139 03/01/1999 Labeler - Major Pharmaceuticals (191427277) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0904-7914) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0904-7914) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(0904-7914) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(0904-7914) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(0904-7914)
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