SPL v4
SPL
SPL Set ID c1576ee9-69ff-41ff-b2d0-7703c8fa8edd
Route
ORAL
Published
Effective Date 2023-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (62.5 mg)
Inactive Ingredients
Maltodextrin Sucralose Polyethylene Glycol, Unspecified Glycerin Silodrate Hypromellose, Unspecified Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-20

Description

Simethicone 62.5 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 62.5 mg

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

Active Ingredient (in Each Strip)

Simethicone 62.5 mg

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)

30's PACK CARTON

NDC 82918-001-02

ANTI-GAS STRIPS

Simethicone 62.5 mg

Quick Dissolving Oral Strips

•     Easy Peel-Open Pouches

•     Pleasant Taste

•     Relieves Gas

MINT FLAVOR

30 Strips

(packed individually)


Structured Label Content

Use

For the relief of

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

Antigas

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

Active Ingredient (in Each Strip) (Active Ingredient (in each strip))

Simethicone 62.5 mg

Package Label.principal Display Panel (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)

30's PACK CARTON

NDC 82918-001-02

ANTI-GAS STRIPS

Simethicone 62.5 mg

Quick Dissolving Oral Strips

•     Easy Peel-Open Pouches

•     Pleasant Taste

•     Relieves Gas

MINT FLAVOR

30 Strips

(packed individually)


Advanced Ingredient Data


Raw Label Data

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