Active Ingredient(S)
Simethicone 250 mg
Gas Relief Capsule, Liquid Filled
FDA Label NDC 69168-434
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Gas Relief (NDC 69168-434). 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(s), purpose, use(s), 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(S)
Relieves bloating, pressure or fullness commonly referred to as gas
Stop Use And Ask A Doctor If
condition persists
Directions
- Swallow 1 or 2 softgels as symptoms occur
- Do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician.
Other Information
- store at room temperature (59°– 86°F) 15°– 30°C
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink
Questions
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Principal Display Panel
Gas Relief (434 Gas Relief 1)
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