Label: SIMETHICONE tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-0791-1, 17856-0791-2 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 57896-791
- Category: HUMAN OTC DRUG LABEL
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 19, 2022
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- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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- package Label
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INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0791(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:17856-0791-1 50 in 1 BOX 04/11/2022 1 NDC:17856-0791-2 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 02/10/2022 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Registrant - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations UNIT DOSE SOLUTIONS 360804194 repack(17856-0791)