FDA Label for Ibuprofen
View Indications, Usage & Precautions
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Remedyrepack Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
How Supplied
400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500
600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500
800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side)
Principal Display Panel
DRUG: IBUPROFEN
GENERIC: IBUPROFEN
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-2432-0
COLOR: white
SHAPE: ROUND
SCORE: No score
SIZE: 13 mm
IMPRINT: 121
PACKAGING: 21 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- IBUPROFEN 400mg in 1
- POLYETHYLENE GLYCOLS
- STARCH, PREGELATINIZED CORN
- POLYVINYL ALCOHOL
- TALC
- SILICON DIOXIDE
- CELLULOSE, MICROCRYSTALLINE
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- TITANIUM DIOXIDE
INACTIVE INGREDIENT(S):
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