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FDA Drug information

IBUPROFEN

Read time: 1 mins
Marketing start date: 01 May 2024

Summary of product characteristics


Effective Time

20231002

Version

2

Spl Product Data Elements

IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN 122

Application Number

ANDA090796

Brand Name

IBUPROFEN

Generic Name

IBUPROFEN

Product Ndc

70518-3313

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL DRUG: IBUPROFEN GENERIC: IBUPROFEN DOSAGE: TABLET, FILM COATED ADMINSTRATION: ORAL NDC: 70518-3313-0 COLOR: white SHAPE: CAPSULE SCORE: No score SIZE: 18 mm IMPRINT: 122 PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): IBUPROFEN 600mg in 1 INACTIVE INGREDIENT(S): SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE MM1

Spl Medguide

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 MEDGUIDE IBUPROFEN TABLETS

How Supplied

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

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Disclaimer

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