FDA Label for Gas-x Total Relief Maximum Strength

View Indications, Usage & Precautions

Gas-x Total Relief Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (Per Tablet)



Calcium carbonate 750 mg

Simethicone 250 mg


Purpose



Antacid

Antigas


Uses



for the relief of

  • •pressure, bloating, and fullness commonly referred to as gas
  • •gas associated with heartburn, sour stomach, or acid indigestion
  • •acid indigestion
  • •heartburn
  • •sour stomach
  • •upset stomach associated with these symptoms

Ask A Doctor Or Pharmacist Before Use If You Are



presently taking a prescription drug. Antacids may interact with certain prescription drugs.


When Using This Product



  • •do not exceed 2 tablets in 24 hours except under the advice and supervision of a doctor
  • •do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor

Directions



  • adults and children 12 years and older: chew 1 or 2 tablets as symptoms occur, or as directed by a doctor. Chew or crush tablets completely before swallowing.
  • •do not take for symptoms that persist for more than 2 weeks, unless advised by a doctor

Other Information



  • each tablet contains: elemental calcium 295 mg
  • •store in a cool, dry place at no higher than 25°C (77°F)

Inactive Ingredients



alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, corn syrup, dextrin, ethyl acetate, FD&C yellow 6, FD&C yellow 6 lake, flavor, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, pharmaceutical ink, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil (coconut origin)


Questions Or Comments?



1-855-328-5204


Additional Information



DO NOT USE IF POUCH IS OPEN OR TORN.

Dist. by: GSK CH, Warren, NJ 07059

Trademarks owned or licensed by GSK.

©2021 GSK or licensor.

Provides gas and heartburn relief

1001388


Principal Display Panel



NEW #1 DOCTOR RECOMMENDED BRAND

NDC 0067-0119-01

Gas-X

TOTAL RELIEF*

Simethicone / Antigas

Calcium Carbonate / Antacid

*Provides gas and heartburn relief

Fast Relief

√ GAS √ HEARTBURN √ BLOATING √ DISCOMFORT

MAXIMUM

STRENGTH

250 mg Simethicone

Mixed Berries

2 Chewable Tablets

1001388 – Front Pouch


* Please review the disclaimer below.