Label: ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled
- NDC Code(s): 79481-0037-5
- Packager: Meijer Distribution Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 14, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel) Simethicone 180 mg
- Purpose Antigas
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions ■adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime ■ do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
- Other information ■ store at a controlled room temperature 20-25°C (68-77°F) ■ protect from heat and moisture
- Inactive ingredients FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide
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INGREDIENTS AND APPEARANCE
ULTRA STRENGTH GAS RELIEF
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0037 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 180 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) POVIDONE K30 (UNII: U725QWY32X) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (opaque) Score no score Shape OVAL Size 15mm Flavor GRAPE Imprint Code 161;910 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0037-5 5 in 1 CARTON 12/14/2023 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M002 12/14/2023 Labeler - Meijer Distribution Inc. (006959555)
