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Gas-X Extra Strength by Novartis Consumer Health

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 125mg
Labeler: Novartis Consumer Health
NDC Code: 0067-0129

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 125 mg

Purpose

Antigas

Uses

for the relief of

• pressure, bloating, and fullness 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 4 tablets in 24 hours except under the advice and supervision of a physician

Other information

each tablet contains: calcium 45 mg

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

protect from moisture

Inactive Ingredients

calcium phosphate tribasic, colloidal silicon dioxide, D&C Red 30

aluminum lake, D&C Yellow 10 aluminum lake, dextrose, flavors, maltodextrin, starch

Questions or comments?

call 1-800-452-0051

www.gas-x.com

Principal Display Panel
GAS-X  EXTRA STRENGTH
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0129
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
TRIBASIC CALCIUM PHOSPHATE 
SILICON DIOXIDE 
D&C RED NO. 30 
D&C YELLOW NO. 10 
DEXTROSE 
MALTODEXTRIN 
PROPYLENE GLYCOL 
SOY PROTEIN 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize14mm
FlavorPEPPERMINT (Peppermint Creme) Imprint CodeGas;X;ES
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-0129-484 BLISTER PACK in 1 CARTON
112 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:0067-0129-182 BLISTER PACK in 1 CARTON
29 TABLET, CHEWABLE in 1 BLISTER PACK
3NDC:0067-0129-273 BLISTER PACK in 1 CARTON
39 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 (879821635)

Revised: 10/2014
 
Novartis Consumer Health

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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