Metformin Hcl Tablet, Film Coated
FDA Label NDC 49483-620

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc for the product Metformin Hcl (NDC 49483-620). 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, 500mg label, 850mg label, 1000mg label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

How Supplied

METFORMIN HYDROCHLORIDE TABLETS, USP 500 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, ROUND SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "134" ON ONE SIDE AND PLAIN ON THE OTHER SIDE. BOTTLES OF 100 AND 500.

METFORMIN HYDROCHLORIDE TABLETS, USP 850 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, ROUND SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "131" ON ONE SIDE AND PLAIN ON THE OTHER SIDE.  BOTTLES OF 100 AND 500.

METFORMIN HYDROCHLORIDE TABLETS, USP 1000 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, OVAL SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "132" ON ONE SIDE AND PLAIN ON THE OTHER SIDE. BOTTLES OF 100 AND 500.

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