Ibuprofen
FDA Label NDC 67296-1685

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Redpharm Drug, Inc. for the product Ibuprofen (NDC 67296-1685). 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, 400mg ibuprofen 100 count label, 400 mg 500 count label, 600 mg 100 count label, 800 mg 100 count label, 600 mg 500 count label, 800 mg 500 count label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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)

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