IBUPROFEN tablet, film coated
Ibuprofen by
Drug Labeling and Warnings
Ibuprofen by is a Otc medication manufactured, distributed, or labeled by L&R Distributors, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredient (in each brown tablet)
- Purpose
- Uses
-
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
- rash
- skin reddening
- 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
- 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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have asthma
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
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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
TAMPER EVIDENT: Use Only if This Blister is Intact
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the lower price name brandNDC: 15127-312-19
IBUPROFEN
TABLETS USP, 200 mg
PAIN RELIEVER / FEVER REDUCER (NSAID)†Compare to the active ingredient of Advil®
8 TABLETS
†This product is not manufactured or distributed by Pfizer Consumer Healthcare,
owner of the registered trademark Advil® Tablets. 50844 ORG011229119Distributed by:
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Pine Bluff, AR 71603 USA
AC(870) 535-3635select
brand®
SATISFACTION
GUARANTEED
Select Brand 44-291
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 15127-312 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) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 15127-312-19 1 in 1 PACKAGE 05/24/1988 09/10/2021 1 8 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC: 15127-312-50 1 in 1 CARTON 05/24/1988 09/10/2021 2 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC: 15127-312-24 1 in 1 CARTON 05/24/1988 09/10/2021 3 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC: 15127-312-01 1 in 1 CARTON 05/24/1988 09/10/2021 4 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC: 15127-312-25 1 in 1 CARTON 05/24/1988 09/10/2021 5 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 6 NDC: 15127-312-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/1988 09/10/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 05/24/1988 09/10/2021 Labeler - L&R Distributors, Inc. (012578514) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(15127-312) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(15127-312) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(15127-312) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(15127-312) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(15127-312)
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