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 (per soft gel)

Simethicone 125 mg

Purpose

Antigas

Uses

Relieves pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children

Directions

• Do not exceed 4 softgels in 24 hours
• Adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  

Other information

store at 200 - 250C

Inactive ingredients

D and C yellow 10, FD and C blue 1, FD and C red 40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

PRINCIPAL DISPLAY PANEL

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children

INGREDIENTS AND APPEARANCE

SIMETHICONE 
dimethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48769-113
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	RP113
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48769-113-99	5000 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