Active Ingredient (In Each Tablet)
Simethicone 80 mg
Simethicone
FDA Label NDC 17856-0791
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Simethicone (NDC 17856-0791). 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, calcium phosphate.
Questions Or Comments?
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
Package Label
Image Description (17856 0791 01)
* Please review the disclaimer below.
