FDA Label for Firstcare Maximum Strength Gas Relief Simethicone 250 Mg Anti-gas

View Indications, Usage & Precautions

Firstcare Maximum Strength Gas Relief Simethicone 250 Mg Anti-gas Product Label

The following document was submitted to the FDA by the labeler of this product Uspharma Ltd. 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 Chewable)



Simethicone, 250 mg


Purpose



Antigas


Uses



for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Keep Out Of Reach Of Children.



In case of accidental overdose, seek professional assistance or contact a poison control center immediately.


Directions



  • adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime.
  • do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.

Other Information



  • each chewable contains  sodium 5 mg. very low sodium
  • store at controlled room temperature 20-25°C (68-77°F).
  • protect from light, heat and moisture.
  • Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive Ingredients:



carnauba wax, citric acid, croscarmellose sodium, crospovidone, FD&C red #40, flavors, glucose syrup, glycerin, gum arabic, maltitol solution,mannitol, powdered milk, propylene glycol, sorbitol, starch, sucralose, sucrose.


Questions Or Comments?



Call 1-800-227-6151


Principal Display Panel-250 Mg Bottle Label



FIRSTCARE

MADE IN USA

NDC 71594-707-08

MAXIMUM STRENGTH

GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

Fast Relief of:

Bloating, Pressure,
Gas discomfort

Mixed Berry Flavor

20 SOFT CHEWABLES


* Please review the disclaimer below.