FDA Label for Simethicone 125 Mg
View Indications, Usage & Precautions
Simethicone 125 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Reliable 1 Laboratires Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Mylanta®
Distributed by: Reliable 1 Laboratories LLC
Valley Stream, NY 11580
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
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, peppermint flavor, sorbitol, stearic acid
Questions Or Comments?
call 516-341-0666, 8:30 am -4:30 pm ET, Monday - Friday
Package Label.Principal Display Panel
NDC 69618-032-06
Simethicone 125 mg
ANTIFLATULENT
60 CHEWABLE TABLETS
*Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH
* Please review the disclaimer below.