The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc for the product Ibuprofen (NDC 49483-604). 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 how supplied, 400mg ibuprofen package label, 600mg ibuprofen package label, 800mg ibuprofen package 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
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