Gas-X Extra Strength Softgels

Dosage form: capsule, liquid filled
Ingredients: DIMETHICONE 125mg
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-6275

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

Use

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 SOFTGELS
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6275
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
HYPROMELLOSES 
PEPPERMINT OIL 
WATER 
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint CodeG;X
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-6275-303 BLISTER PACK in 1 CARTON
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:0067-6275-101 BLISTER PACK in 1 CARTON
210 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
3NDC:0067-6275-202 BLISTER PACK in 1 CARTON
310 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
4NDC:0067-6275-505 BLISTER PACK in 1 CARTON
410 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33209/12/2011
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 10/2014
 
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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