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Drug Facts
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Reliable 1 Laboratories LLC
Valley Stream, NY 11580
Simethicone 80 Mg Tablet, Chewable
FDA Label NDC 69618-033
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Simethicone 80 Mg (NDC 69618-033). 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, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
relieves bloating, pressure and fullness commonly referred to as gas
Warnings
Keep out of reach of children
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 then 6 tablets per day
Other Information
store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
compressible sugar, dextrose, maltodextrin, peppermint flavor, sorbitol, stearic acid
Questions Or Comments?
call 516-341-0666, 8:30 am to 4:30 pm ET, Monday - Friday
Active Ingredient (In Each Chewable Tablet)
Simethicone 80 mg
Purpose
Antiflatulent
Package Label.Principal Display Panel
NDC 69618-033-01
Simethicone 80 mg
ANTIFLATULENT
100 CHEWABLE TABLETS
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