Label: SIMETHICONE tablet, chewable
- NDC Code(s): 71610-649-04
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- 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 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Directions
- Other information
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HOW SUPPLIED
Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "44 & 137" on one side and are supplied as:
NDC 57896-791-01 in bottle of 100 chewable tablets
NDC 57896-791-08 in bottle of 80 chewable tablets
Distributed by:
GERI-CARE Pharmaceuticals Corp.
1650 63rd Street, Brooklyn, NY 11204
- Inactive ingredients
- Questions or comments?
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Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 80 mg 4 71610-649-04 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20220519JK - PRINCIPAL DISPLAY PANEL - 80 mg
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INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-649(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:71610-649-04 4 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 01/01/2004 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-649)
