Ibuprofen Tablet, Film Coated
FDA Label NDC 70518-3313

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Remedyrepack Inc. for the product Ibuprofen (NDC 70518-3313). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding ibuprofen tablets 400 mg - 600 mg- 800 mg medguide, how supplied, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

600 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘122’ on one side and plain on other side)

NDC: 70518-3313-00

PACKAGING: 30 in 1 BLISTER PACK

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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

      • Remedy_label (Remedy Label)

      Remedy_label (Remedy Label)

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