Fluvoxamine Maleate Extended-release Capsule, Extended Release
FDA Label NDC 70771-1957

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 Fluvoxamine Maleate Extended-release (NDC 70771-1957). 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

Fluvoxamine Maleate Extended -Release Capsules, 100 mg

NDC 70771-1957-3

Bottles of 30 capsules

Rx only

100 mg Label (D45aa001 Af6b 41f2 Ac88 C72411621202 01)

100 mg Label (D45aa001 Af6b 41f2 Ac88 C72411621202 01)

Fluvoxamine Maleate Extended -Release Capsules, 150 mg

NDC 70771-1958-3

Bottles of 30 capsules

Rx only

150 mg Label (D45aa001 Af6b 41f2 Ac88 C72411621202 02)

150 mg Label (D45aa001 Af6b 41f2 Ac88 C72411621202 02)

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