FDA Label for Premier Value Extra Strength

View Indications, Usage & Precautions

Premier Value Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, 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


Uses



For the relief of

  • ▪Pressure, bloating and fullness commonly referred to as gas

Directions



  • adults: chew 1 to 2 tablets as needed after meals and at bedtime.
  • •do not exceed 4 tablets in a 24 hours except under the advice and supervision of a physician.

Other Information



  • each tablets contains: calcium 45 mg
  • •store at room temperature
  • •protect from excessive heat and moisture
  • DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN


Inactive Ingredients



D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate.


Principal Display Panel



Premier Value®

NDC 68016-811-18

*Compare to the active ingredient in Gas-X® Extra Strength

Extra Strength

Gas Relief

Antigas/Simethicone 125 mg

Relieves:

  • •Pressure
  • •Bloating
  • •Discomfort
  • Cherry Creme Flavor

    Naturally and Artificially Flavored

    18 CHEWABLE TABLETS

    K PAREVE

    *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. the distributor of Gas-X® Extra strength.

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    IMPORTANT: Keep this carton for future reference on full labeling.


* Please review the disclaimer below.