Anti-gas Strip
FDA Label NDC 82918-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Calmour for the product Anti-gas Strip (NDC 82918-001). 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 ingredient (in each strip), purpose, use, warnings, directions, other information, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 (F1ee1b02 F1f1 4f3b Aad6 48653324083c 01)

Pouch (F1ee1b02 F1f1 4f3b Aad6 48653324083c 01)

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)

Inner Box (F1ee1b02 F1f1 4f3b Aad6 48653324083c 02)

Inner Box (F1ee1b02 F1f1 4f3b Aad6 48653324083c 02)

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)

Outer Box (F1ee1b02 F1f1 4f3b Aad6 48653324083c 03)

Outer Box (F1ee1b02 F1f1 4f3b Aad6 48653324083c 03)

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