SIMETHICONE - dimethicone capsule, liquid filled
Softech Pharma Pvt. Ltd.

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.

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SIMETHICONE Capsules 180 mg

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Uses

Relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask doctor if condition persists

Keep out of Reach of Children

Directions

Swallow one or two softgels as needed after a meal
Do not exceed two softgels per day except under the advise and supervision of a physician

Other Information

Each softgel contains: potassium 5 mg
Store at 200 - 250C

Inactive ingredients:

FD and C Red No. 40, FD and C yellow No. 6, Gelatin, Glycerol

carton label for 180 mg

SIMETHICONE
dimethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48769-112
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	RP112
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:48769-112-99	1000 in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	01/15/2012

Labeler - Softech Pharma Pvt. Ltd. (677111277)

Name	Address	ID/FEI	Business Operations
Establishment
Softech Pharma Pvt. Ltd.		677111277	manufacture