Otc - Active Ingredient
Ursodeoxycholic Acid, Pancreatin, Simethione
Festal Plus
FDA Label NDC 72689-0010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oasis Trading for the product Festal Plus (NDC 72689-0010). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
digestion
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
children under 7 years of age: consult a doctor
take 1-2 tablet as symptoms accur, as directed by a doctor
Warnings
Ask a doctor before use if you have taking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product
■ Do not take more than 4 tablet in 24 hours
■ Do not use the maximum dosage for more than 2 weeks
Keep out of reach of children
Inactive Ingredient
Dextrin, stearic acid, talc, polyethylene glycol 6000, Cellulase AP3
Dosage & Administration
For oral use only
* Please review the disclaimer below.
