Label: SIMETHICONE tablet, chewable
- NDC Code(s): 68071-2746-3
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 57896-791
- 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 June 2, 2022
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- Active ingredient (in each tablet)
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INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-2746(NDC:57896-791) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) DEXTRATES (UNII: G263MI44RU) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white Score no score Shape ROUND Size 13mm Flavor PEPPERMINT Imprint Code 44;137 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-2746-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 01/01/2004 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 repack(68071-2746)