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Gas-X Extra Strength by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

Medically reviewed on May 8, 2018

Dosage form: gel
Ingredients: SIMETHICONE 125mg
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.
NDC Code: 0067-0134

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 125mg

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: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information
store at controlled room temperature 20-25o C (68-77o F)
Protect from light, heat, and moisture

Inactive ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

call 1-800-452-0051

Principal Display Panel
GAS-X  EXTRA STRENGTH
simethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0134
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN, UNSPECIFIED 
GLYCERIN 
HYPROMELLOSE, UNSPECIFIED 
PEPPERMINT OIL 
WATER 
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:0067-0134-8212 BLISTER PACK in 1 CARTON
110 GEL in 1 BLISTER PACK
2NDC:0067-0134-726 BLISTER PACK in 1 CARTON
212 GEL in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33205/18/201703/31/2019
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

← See all Gas-X Extra Strength brands

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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