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, 125 mg

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

simethicone capsules 125 mg label

Keep out of Reach of Children

SIMETHICONE
dimethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48769-113
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	125 mg

Ingredient Name	Strength
Inactive Ingredients
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

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