Label: IBUPROFEN tablet, film coated
- NDC Code(s): 50844-352-02, 50844-352-12, 50844-352-15, 50844-352-16
- Packager: L.N.K. International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 26, 2024
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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:
- hives
- facial swelling
- asthma (wheezing)
- skin reddening
- shock
- rash
- 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
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 problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- under a doctor’s care for any serious condition
- taking any other drug
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- weakness in one part or side of body
- leg swelling
- slurred speech
- trouble breathing
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- any new symptoms appear
- redness or swelling is present in the painful area
-
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
Quality
+PlusNDC 50844-352-16
†Compare to active ingredient
in Motrin® IB TabletsIBUPROFEN
TABLETS
USP, 200 mgPAIN RELIEVER/FEVER REDUCER
(NSAID)1000 Coated Tablets
ACTUAL SIZE
TAMPER 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 REV1221C35216
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA
Quality Plus 44-352
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-352 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;352 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50844-352-02 1 in 1 CARTON 03/01/1999 1 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:50844-352-15 1 in 1 CARTON 03/01/1999 2 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:50844-352-12 1 in 1 CARTON 03/01/1999 3 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:50844-352-16 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075139 03/01/1999 Labeler - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(50844-352) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(50844-352) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(50844-352) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(50844-352) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(50844-352)