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 (per softgel)

Simethicone 125 mg

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 a controlled room temperature 20-25°C (68-77°F)
  • protect from light, heat and moisture

Inactive ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, light mineral oil*, mannitol, medium chain triglycerides*, peppermint oil, purified water, sorbitol, soy lecithin*, titanium dioxide.
*may contain these ingredients

Questions or comments?

call 1-800-452-0051

Package/Label Principal Display Panel

NDC 0067-6275-10

Gas-X®

SOFTGELS
ANTIGAS ● SIMETHICONE 125 mg

EXTRA STRENGTH

RELIEVES GAS FAST

Pressure ● Bloating ● Discomfort

10 Softgels

Gas-X® Extra Strength Softgels offer fast, effective relief of pressure and bloating that antacids can't provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating or discomfort referred to as gas.

Gas-X® Extra Strength Softgels are concentrated to contain liquid gas-fighting medicine in a small softgel so they are easy to swallow, and there is no chalky taste.

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 
MANNITOL 
PEPPERMINT OIL 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
LIGHT MINERAL OIL 
MEDIUM-CHAIN TRIGLYCERIDES 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint CodeG;X
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-6275-101 BLISTER PACK (BLISTER PACK) in 1 CARTON
110 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
2NDC:0067-6275-202 BLISTER PACK (BLISTER PACK) in 1 CARTON
210 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
3NDC:0067-6275-505 BLISTER PACK (BLISTER PACK) in 1 CARTON
310 CAPSULE, LIQUID FILLED (CAPSULE) 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: 03/2011
 
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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