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SIMETHICONE by Softech Pharma Pvt. Ltd.

Medically reviewed on June 29, 2017

Dosage form: capsule, liquid filled
Ingredients: DIMETHICONE 180mg
Labeler: Softech Pharma Pvt. Ltd.
NDC Code: 48769-112

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 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

SIMETHICONE 
dimethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48769-112
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
Product Characteristics
ColorredScoreno score
ShapeOVALSize8mm
FlavorImprint CodeRP112
Contains    
Packaging
#Item CodePackage Description
1NDC:48769-112-991000 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. Ltd.677111277manufacture

 
Softech Pharma Pvt. Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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