The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Simethicone 125 Mg (NDC 82804-152). 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.
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
Repackaged by: Proficient Rx LP
Thousand Oaks, CA 91320
Simethicone 125 mg
Antiflatulent
relieves bloating, pressure and fullness commonly referred to as gas
Keep out of reach of children
Keep out of reach of children
store at room temperature 15°-30°C (59°-86°F)
compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid
call 516-341-0666, 8:30 am -4:30 pm ET, Monday - Friday
NDC 82804-152-09
Simethicone 125 mg
ANTIFLATULENT
9 CHEWABLE TABLETS
*Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH
82804-152-09 (1)
* Please review the disclaimer below.
