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Drug Facts
Simethicone 125 Mg Tablet, Chewable
FDA Label NDC 17856-0137
12 label sections · Submitted to the FDA by Atlantic Biologicals Corp. · 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 125 Mg (NDC 17856-0137). 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 other, active ingredient (in each chewable tablet), otc - purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Chewable Tablet)
Simethicone 125 mg
Otc - Purpose
Antiflatulent
Use
relieves bloating, pressure and fullness commonly referred to as gas
Warnings
Keep out of reach of children
TAMPER EVIDENT: DO NOT USE IF SAFETY POUCH LOOKS TO BE TEMPERED OR OPEN
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
- thoroughly chew 1-2 tablets as needed after meals and at bedtime
- do not take more than 4 tablets per day
Other Information
store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid
How Supplied
NDC 17856-0137-01
Box of 100 Chewable Tablets.................................. 17856-0137-01
ANTIFLATULENT
Questions Or Comments?
Distributed by:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
Call 1-800-509-7592
M-F 8 am - 5 pm EST
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