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Simethicone by Softech Pharma Pvt. Ltd

Medically reviewed on June 29, 2018

Dosage form: capsule, liquid filled
Ingredients: Dimethicone 125mg
Labeler: Softech Pharma Pvt. Ltd
NDC Code: 48769-113

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.

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

Keep out of Reach of Children

SIMETHICONE 
dimethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48769-113
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
MANNITOL 
PEPPERMINT OIL 
WATER  
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize5mm
FlavorImprint CodeRP113
Contains    
Packaging
#Item CodePackage Description
1NDC:48769-113-995000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/15/2012
Labeler - Softech Pharma Pvt. Ltd (677111277)
Establishment
NameAddressID/FEIOperations
Softech Pharma Pvt. Ltd677111277manufacture

 
Softech Pharma Pvt. Ltd

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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