SIMETHICONE- dimethicone tablet, chewable

Simethicone by

Drug Labeling and Warnings

Simethicone by is a Otc medication manufactured, distributed, or labeled by Innovida Pharmaeutique Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Simethicone 125 mg

Purpose

Anti-gas

Uses

Relieves:

• pressure 
• bloating 
• symptoms referred to as gas

Warnings

KEEP OUT OF REACH OF CHILDREN. In case of an overdose, get medical help or contact a Poison Control Center immediately

KEEP OUT OF REACH OF CHILDREN

Directions

• chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
• do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Other Information

• do not use if inner seal is broken
• store at room temperature
• avoid high humidity and excessive heat, above 40°C (104° F)

Inactive Ingredients

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

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Product label

INGREDIENTS AND APPEARANCE

SIMETHICONE 
dimethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71800-055
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
SUGARCANE (UNII: 81H2R5AOH3)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71800-055-06	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	02/10/2025

Labeler - Innovida Pharmaeutique Corporation (080892908)