FDA Label for Gas Relief

View Indications, Usage & Precautions

Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates, 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 Ingredient(In Each Tablet)



Simethicone 125 mg


Purpose



Anti-gas


Use(S)



relieves:

  • pressure
  • bloating
  • symptoms referred to as gas

Warnings



.


Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a poison control center immediately.


Directions



  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 4 tablets in a 24 hour period except under the advice and supervision of  a physician

Other Information



  • do not use if any individual blister unit is broken or open
  • store at room temperature
  • avoid high humidity and excessive heat, above 40°C (104°F)

Inactive Ingredients



D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose


Principal Display Panel



Topcare
NDC 36800-122-73
COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*
EXTRA STRENGTH
Gas
Relief

ANTI-GAS/SIMETHICONE, 125 mg

FAST RELIEF OF:

  • Bloating
  • Pressure
  • Discomfort of Gas
  • CHERRY FLAVOR

    18 CHEWABLE TABLETS


* Please review the disclaimer below.