SIMETHICONE- dimethicone capsule, liquid filled

SIMETHICONE by

Drug Labeling and Warnings

SIMETHICONE by is a Otc medication manufactured, distributed, or labeled by Softech Pharma Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMETHICONE 
dimethicone capsule, liquid filled

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Softech Pharma Pvt. Ltd. (677111277)

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