Label: SIMETHICONE 125 MG- simethicone tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-0137-1, 17856-0137-2 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 69618-032
- 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 September 29, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable tablet)
- PURPOSE
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIMETHICONE 125 MG
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0137(NDC:69618-032) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) MALTODEXTRIN (UNII: 7CVR7L4A2D) PEPPERMINT (UNII: V95R5KMY2B) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) DEXTROSE (UNII: IY9XDZ35W2) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white (Off white) Score 2 pieces Shape ROUND Size 16mm Flavor Imprint Code AP;040 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-0137-1 100 in 1 BOX, UNIT-DOSE 09/29/2022 1 NDC:17856-0137-2 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 04/25/2018 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations UNIT DOSE SOLUTIONS 360804194 repack(17856-0137)
