Active Ingredient
(in each softgel)
Simethicone 180mg
Phazyme Capsule, Gelatin Coated
FDA Label NDC 0132-0208
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Phazyme (NDC 0132-0208). 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 active ingredient, purpose, use, stop use and ask a doctor if, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-gas
Use
relieves bloating, pressure or fullness commonly referred to as gas
Stop Use And Ask A Doctor If
condition persists
Directions
- swallow one or two softgels after a meal
- do not exceed two softgels per 24 hours except under the advice and supervision of a physician
Other Information
- store at room temperature 59° - 86°F (15° - 30°C)
Inactive Ingredients
FD&C Yellow No. 6, Gelatin, Glycerin, White Edible Ink
Questions?
Call toll-free 1-855-727-4277
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