Active Ingredient (In Each Tablet)
Simethicone 80 mg
Gas Relief
FDA Label NDC 80136-791
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Northeast Pharma for the product Gas Relief (NDC 80136-791). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Gas
Uses
relieves pressure, bloating, and fullness
commonly referred to as gas
Warnings
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- chew or crush tablet completely before swallowing
- adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime.
- children under 12 years: ask a doctor
Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.
Other Information
- each tablet contains: calcium 65 mg
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken
- store at room temperature, 15°C - 30°C (59˚F - 86˚F)
- protect from moisture
Inactive Ingredients
cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
magnesium stearate, silica, sucralose, tricalcium phosphate.
Questions Or Comments?
1-800-540-3765
Package Label
1 (Hpc791)
* Please review the disclaimer below.
