GAS-X EXTRA STRENGTH - dimethicone tablet, chewable
Novartis Consumer Health Inc.

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.

----------

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?

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

Package/Label Principal Display Panel

GAS-X EXTRA STRENGTH
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-0129
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (DIMETHICONE)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE
DEXTROSE
MALTODEXTRIN
STARCH, CORN

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	14mm
Flavor	PEPPERMINT (Peppermint Creme)	Imprint Code	Gas;X;ES
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0067-0129-18	2 BLISTER PACK in 1 CARTON	contains a BLISTER PACK
1		9 TABLET, CHEWABLE in 1 BLISTER PACK	This package is contained within the CARTON (0067-0129-18)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	01/01/2012

Labeler - Novartis Consumer Health Inc. (879821635)

Establishment
Name	Address	ID/FEI	Operations
Novartis Ex-Lax Inc.		090478330	MANUFACTURE

Revised: 01/2012 Novartis Consumer Health Inc.