Theophylline Tablet, Extended Release
FDA Label NDC 70771-1783

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 Theophylline (NDC 70771-1783). 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

Theophylline extended-release tablets, 300 mg

100 Tablets

NDC 70771-1782-1

Rx only

Theophylline Extended-release Tablets 300mg (86fdabb8 C881 4695 8127 59b26998e365 01)

Theophylline Extended-release Tablets 300mg (86fdabb8 C881 4695 8127 59b26998e365 01)

Theophylline extended-release tablets, 450 mg

100 Tablets

NDC 70771-1783-1

Rx only

Theophylline Extended-release Tablets 450 mg (86fdabb8 C881 4695 8127 59b26998e365 02)

Theophylline Extended-release Tablets 450 mg (86fdabb8 C881 4695 8127 59b26998e365 02)

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