FDA Label for Anti-gas Strip

View Indications, Usage & Precautions

Anti-gas Strip Product Label

The following document was submitted to the FDA by the labeler of this product Calmour. 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 Strip)



Simethicone 62.5 mg


Purpose



Antigas


Use



For the relief of

  • Pressure
  • Bloating
  • Fullness commonly referred to as gas.

Warnings



  • Keep out of reach of children.

Directions



  • Adults and children 12 years and older: dissolve 1 or 2 oral strips on tongue when symptoms occur.
  • Do not exceed more than 8 strips within 24 hours except under the advice of supervision of a medical physician.

Other Information



  • Use strip immediately after opening.
  • Store below 77°F (25°C). Protect from heat, light and moisture.

Inactive Ingredients



Maltodextrin, Sucralose, Polyethylene Oxide, Glycerol, Magnesium Aluminometasilicate, Hypromellose, FD & C Blue 1, Cool Mint KAL 1080.

Questions or comments?

Call 1-802-861-4111

Monday-Friday

9AM-5PM EST

Distributed by:

Calmour, LLC

1775 Williston Road

South Burlington, VT 05403

Phone (802) 861-4111

©2022 Calmour, LLC

Made in India


Package Label.Principal Display Panel



POUCH LABEL

NDC 82918-001-01

ANTI-GAS STRIP

Simethicone 62.5 mg

1 STRIP

Pouch

INNER BOX

NDC 82918-001-01

ANTI-GAS STRIPS

 Simethicone 62.5 mg

Quick Dissolving Oral Strips

•     Easy Peel-Open Pouches

•     Pleasant Taste

•     Relieves Gas

MINT FLAVOR

10 Strips

(packed individually)

OUTER BOX

NDC 82918-001-10

ANTI-GAS STRIPS

 Simethicone 62.5 mg

Quick Dissolving Oral Strips

•     Easy Peel-Open Pouches

•     Pleasant Taste

•     Relieves Gas

MINT FLAVOR

100 Strips

(packed individually)


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