Label: SIMETHICONE CERTIFIED PLUS- simethicone gel
- NDC Code(s): 17714-076-18
- Packager: Advance Pharmaceutical Inc.
- 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 November 11, 2021
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INGREDIENTS AND APPEARANCE
SIMETHICONE CERTIFIED PLUS
simethicone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17714-076 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) GELATIN (UNII: 2G86QN327L) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color orange Score Shape OVAL Size 3mm Flavor Imprint Code PC3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17714-076-18 180 in 1 BOTTLE; Type 0: Not a Combination Product 11/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 11/11/2021 Labeler - Advance Pharmaceutical Inc. (078301063) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(17714-076)