The following Structured Product Label (SPL) was submitted to the FDA by Medsource Pharmaceuticals for the product Ibuprofen (NDC 45865-945). 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, 800 mg 60 count label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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)
Pdp (945)
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