Label: SIMETHICONE 80 MG- simethicone tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 70518-3123-0, 70518-3123-1 - Packager: REMEDYREPACK INC.
- 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 June 15, 2021
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- Official Label (Printer Friendly)
- 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
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PRINCIPAL DISPLAY PANEL
DRUG: Simethicone 80 mg
GENERIC: Simethicone
DOSAGE: TABLET, CHEWABLE
ADMINSTRATION: ORAL
NDC: 70518-3123-0
NDC: 70518-3123-1
COLOR: white
SHAPE: ROUND
SCORE: No score
SIZE: 13 mm
IMPRINT: AP;019
PACKAGING: 1 in 1 POUCH
OUTER PACKAGING: 100 in 1 BOX
ACTIVE INGREDIENT(S):
- DIMETHICONE 80mg in 1
INACTIVE INGREDIENT(S):
- CELLULOSE, MICROCRYSTALLINE
- SILICON DIOXIDE
- MALTODEXTRIN
- SORBITOL
- STEARIC ACID
- SUCROSE
- DEXTROSE
- PEPPERMINT
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INGREDIENTS AND APPEARANCE
SIMETHICONE 80 MG
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-3123(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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MALTODEXTRIN (UNII: 7CVR7L4A2D) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) DEXTROSE (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:70518-3123-0 100 in 1 BOX 06/15/2021 1 NDC:70518-3123-1 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 06/15/2021 Labeler - REMEDYREPACK INC. (829572556)