Paroxetine Tablet, Film Coated
FDA Label NDC 65841-099

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 Paroxetine (NDC 65841-099). 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.

Label Section Quick Index

Package Label.Principal Display Panel

NDC 65841-097-05 in pack count of 500 tablets

Paroxetine Tablets USP, 10 mg

Rx only

500 tablets

Paroxetine Tablets, 10 mg (B0140ec7 72b8 4082 8b4f Ecdf96bcc644 02)

Paroxetine Tablets, 10 mg (B0140ec7 72b8 4082 8b4f Ecdf96bcc644 02)

NDC 65841-098-16 in pack count of 90 tablets

Paroxetine Tablets USP, 20 mg

Rx only

90 tablets

Paroxetine Tablets, 20 mg (B0140ec7 72b8 4082 8b4f Ecdf96bcc644 03)

Paroxetine Tablets, 20 mg (B0140ec7 72b8 4082 8b4f Ecdf96bcc644 03)

NDC 65841-099-10 in pack count of 1000 tablets

Paroxetine Tablets USP, 30 mg

Rx only

1000 tablets

Paroxetine Tablets, 30 mg (B0140ec7 72b8 4082 8b4f Ecdf96bcc644 04)

Paroxetine Tablets, 30 mg (B0140ec7 72b8 4082 8b4f Ecdf96bcc644 04)

NDC 65841-601-06 in pack count of 30 tablets

Paroxetine Tablets USP, 40 mg

Rx only

30 tablets

Paroxetine Tablets, 40 mg (B0140ec7 72b8 4082 8b4f Ecdf96bcc644 05)

Paroxetine Tablets, 40 mg (B0140ec7 72b8 4082 8b4f Ecdf96bcc644 05)

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