Gas-x Tablet, Chewable
FDA Label NDC 0067-0118

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Gas-x (NDC 0067-0118). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (per tablet), purpose, uses, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)
  • contains FD&C Yellow 5 Lake (tartrazine) as a color additive

Inactive Ingredients

alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, corn syrup, dextrin, ethyl acetate, FD&C red 40, FD&C red 40 lake, FD&C yellow 5 lake (tartrazine), FD&C yellow 6, FD&C yellow 6 lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, pharmaceutical ink, phosphoric acid, propylene glycol, propylparaben, purified water, shellac,

sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil (coconut origin)

Questions Or Comments?

1-855-328-5204

Additional Information

TAMPER EVIDENT FEATURE: Do not use if printed inner safety seal under cap is broken or missing.

Dist. by: GSK CH, Warren, NJ 07059

Trademarks owned or licensed by GSK.

©2021 GSK or licensor.

1001392

Principal Display Panel

NEW #1 DOCTOR RECOMMENDED BRAND

NDC 0067-0118-03

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

30 Chewable Tablets

1001392 – Front Carton

1001392_gas X Total Relief_30 Chewable Tabs (Image 01)

1001392_gas X Total Relief_30 Chewable Tabs (Image 01)

* Please review the disclaimer below.