Label: SIMETHICONE 80 MG- simethicone tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-5431-3 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 69618-033
- 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 January 14, 2021
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- SPL UNCLASSIFIED SECTION
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable tablet)
- Purpose
- HOW SUPPLIED
- SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE
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INGREDIENTS AND APPEARANCE
SIMETHICONE 80 MG
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-5431(NDC:69618-033) 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MALTODEXTRIN (UNII: 7CVR7L4A2D) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) PEPPERMINT (UNII: V95R5KMY2B) Product Characteristics Color white (Off White) Score no score Shape ROUND Size 13mm Flavor Imprint Code AP;019 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-5431-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/13/2021 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 04/24/2018 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-5431) , REPACK(50090-5431)
