Active Ingredient (In Each Tablet)
Simethicone 80 mg
Mi-acid Gas Relief
FDA Label NDC 33261-224
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Mi-acid Gas Relief (NDC 33261-224). 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 (in each tablet), purpose, uses, warnings, 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
Antigas
Uses
relieves:
- pressure
- bloating
- symptoms referred to as gas
Warnings
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center immediately.
Directions
- chew 2 to 4 tablets thoroughly as needed after meals and at bedtime.
- do not exceed 6 tablets per day unless directed by a physician.
Other Information
- do not use if inner seal is broken.
- store at room temperature
- avoid high humidity and excessive heat, above 400C (1040F)
Inactive Ingredients
compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol
Questions
To Report Adverse Drug Event Call: (800) 616-2471
Pdp
Mi-Acid Gas Relief
Relieves Gas Pain, Pressure and Bloating
Simethicone 80 mg/Antiflatulent
30 Chewable Tablets
Image Label (Simethicone Chewable Tabs 80mg For Major 1)
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