Pancrelipase Capsule, Delayed Release Pellets
FDA Label NDC 54809-1024

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Abbott Laboratories Gmbh for the product Pancrelipase (NDC 54809-1024). 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 description, caution:, storage and handling, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Pancrelipase, 3000 Delayed-release Capsules (BULK)

Pancrelipase, 6000 Delayed-release Capsules (BULK)

Pancrelipase, 12000 Delayed-release Capsules (BULK)

Pancrelipase, 24000 Delayed-release Capsules (BULK)

Pancrelipase, 36000 Delayed-release Capsules (BULK)

Caution:

RX ONLY. Caution: for manufacturing, processing or repacking.

Storage And Handling

Store at room temperature up to 25 degrees C (77degrees F) protected from moisture.

Excursions permitted between 25 degrees C to 40 Degrees C (77 degrees F to 104 degrees F) for up to 30 days.

Principal Display Panel

* Please review the disclaimer below.