Lubiprostone Capsule
FDA Label NDC 70771-1763

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 Lubiprostone (NDC 70771-1763). 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

NDC 70771-1763-6

Lubiprostone Capsules, 8 mcg

60 Capsules

Rx only

8 Mcg Label (D529a527 D19e 4cec A117 Ddc6cab4a8b1 01)

8 Mcg Label (D529a527 D19e 4cec A117 Ddc6cab4a8b1 01)

NDC 70771-1764-6

Lubiprostone Capsules, 24 mcg

60 Capsules

Rx only

24 Mcg Label (D529a527 D19e 4cec A117 Ddc6cab4a8b1 02)

24 Mcg Label (D529a527 D19e 4cec A117 Ddc6cab4a8b1 02)

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