Gas-X Regular Strength Chewable Peppermint

Dosage form: tablet, chewable
Ingredients: DIMETHICONE 80mg
Labeler: Novartis Consumer Health Inc.
NDC Code: 0067-0116

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.

Drug Facts

Active ingredient

Simethicone 80 mg ……………………………..……………..………………………………..

Purpose

Antigas

Uses

for the relief of

• pressure and bloating commonly referred to as gas

Warnings

Keep Out of Reach of Children

Directions

adults: chew 1 or 2 tablets as needed after meals and at bedtime

do not exceed 6 tablets in a 24 hours except under the advice and supervision of a

physician

Other information

• each tablet contains: calcium 30 mg

store at controlled room temperature 20-25°C (68-77°F)

protect from moisture

Inactive Ingredients

calcium carbonate, dextrose, flavors, maltodextrin, starch

Questions?

call 1-800-452-0051 24 hours a day, 7 days a week

Package/Label Principal Display Panel
GAS-X  REGULAR STRENGTH CHEWABLE PEPPERMINT
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0116
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
DEXTROSE 
MALTODEXTRIN 
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize14mm
FlavorPEPPERMINT (Peppermint Creme) Imprint CodeGas;X
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-0116-363 BLISTER PACK in 1 CARTON
112 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:0067-0116-605 BLISTER PACK in 1 CARTON
212 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/01/2012
Labeler - Novartis Consumer Health Inc. (879821635)
Establishment
NameAddressID/FEIOperations
Novartis Ex-Lax Inc.090478330MANUFACTURE(0067-0116)

Revised: 01/2012
 
Novartis Consumer Health Inc.

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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