Label: EXTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled
- NDC Code(s): 11673-495-71
- Packager: TARGET CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 6, 2023
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- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH GAS RELIEF
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-495 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) FD&C RED NO. 40 (UNII: WZB9127XOA) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN (UNII: 6O92ICV9RU) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) Product Characteristics Color green Score no score Shape OVAL Size 10mm Flavor Imprint Code 105 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-495-71 3 in 1 CARTON 07/01/2023 1 24 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 final M002 07/01/2023 Labeler - TARGET CORPORATION (006961700) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(11673-495)