Risperidone Tablet, Film Coated
FDA Label NDC 65841-665

1 label section · Submitted to the FDA by Zydus Lifesciences Limited · 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 Risperidone (NDC 65841-665). 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

Risperidone Tablets USP, 0.25 mg

NDC 65841-665-14

60 tablets

Rx only

0.25 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 01)

0.25 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 01)

Risperidone Tablets USP, 0.5 mg

NDC 65841-666-14

60 tablets

Rx only

0.5 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 02)

0.5 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 02)

Risperidone Tablets USP, 1 mg

NDC 65841-667-14

60 Tablets

Rx only

1 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 03)

1 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 03)

Risperidone Tablets USP, 2 mg

NDC 65841-668-14

60 Tablets

Rx only

2 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 04)

2 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 04)

Risperidone Tablets USP, 3 mg

NDC 65841-669-14

60 Tablets

Rx only

3 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 05)

3 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 05)

Risperidone Tablets USP, 4 mg

NDC 65841-670-14

60 Tablets

Rx only

4 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 06)

4 mg (D39bd21c 64bb 4eff 8713 5a5ed9b98c9d 06)

* Please review the disclaimer below.