Active Ingredient(S)
Simethicone 125mg
Anti-gas Capsule
FDA Label NDC 69168-419
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 Anti-gas (NDC 69168-419). 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), directions, other information, storage, 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)
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
Directions
- adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician.
Other Information
- Do not use if blister unit is torn or open
Storage
- store at room temperature 20o-25oC (68o -77oF)
- protect from light, heat and moisture
Inactive Ingredients
D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil,
purified water, white edible ink
Questions
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Principal Display Panel
Simethicone 125mg (419 Anti Gas 1)
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