Mesalamine Capsule, Extended Release
FDA Label NDC 70771-1625

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Mesalamine (NDC 70771-1625). 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 package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

Mesalamine Extended-Release Capsules, 0.375 g

120 capsules

NDC 70771-1625-7

Rx only

Mfg Label (9766ebb4 1686 4e37 B139 1866e73cf182 01)

Mfg Label (9766ebb4 1686 4e37 B139 1866e73cf182 01)

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