- Active Ingredient (In each 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
- skin reddening
- 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 non prescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks everyday while using this product
- take more or for a longer time than directed
- Do not use
- Ask a doctor before use if
- Ask a doctor or pharmacist before use if you are
- when using this product
-
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
- pain gets worse or last for more than 10 days
- fever gets worse or last more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- you experience any of the following signs of stomach bleeding
- if pregnant or breast feeding
- keep out of reach of children
-
Directions
- do not take more than directed
- the smallest effective dose should be used
Adults and children
12 years and older- take 1 tablet every4 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? Adverse drug event call: (800)687-0176
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42254-194(NDC:66424-996) 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown Score no score Shape ROUND Size 9mm Flavor Imprint Code 2I Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42254-194-60 60 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075661 01/27/2011 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK