Label: SIMETHICONE capsule, liquid filled
- NDC Code(s): 73629-002-18
- Packager: AMZ789 LLC
- 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 May 28, 2023
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- ACTIVE INGREDIENT
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- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73629-002 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) Product Characteristics Color orange Score no score Shape OVAL Size 13mm Flavor Imprint Code PC3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73629-002-18 180 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 05/01/2021 Labeler - AMZ789 LLC (117410213) Establishment Name Address ID/FEI Business Operations Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd 421293287 manufacture(73629-002)