GAS-X REGULAR STRENGTH CHEWABLE PEPPERMINT- simethicone tablet, chewable
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-0116
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-0116-36	3 in 1 CARTON	01/01/2012	06/30/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0067-0116-60	5 in 1 CARTON	01/01/2012	06/30/2019
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	01/01/2012	06/30/2019

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 2/2018

Document Id: cd63a094-b1af-4203-a9f5-1c6491d0e500

Set id: 86804088-9f48-4a3b-9be3-17bad6e26a81

Version: 2

Effective Time: 20180220

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC