ANTI-GAS STRIP- simethicone strip

Anti-Gas Strip by

Drug Labeling and Warnings

Anti-Gas Strip by is a Otc medication manufactured, distributed, or labeled by Calmour, Shilpa Medicare Limited, Unit-VI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

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)

INGREDIENTS AND APPEARANCE

ANTI-GAS STRIP 
simethicone strip

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82918-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	62.5 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
GLYCERIN (UNII: PDC6A3C0OX)
SILODRATE (UNII: 9T3UU8T0QK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82918-001-10	10 in 1 CARTON	07/20/2023
1	NDC: 82918-001-01	10 in 1 CARTON
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 82918-001-02	30 in 1 CARTON	07/20/2023
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	07/20/2023

Labeler - Calmour (118597110)

Registrant - Shilpa Medicare Limited, Unit-VI (854193706)

Establishment
Name	Address	ID/FEI	Business Operations
Shilpa Medicare Limited, Unit-VI		854193706	ANALYSIS(82918-001) , MANUFACTURE(82918-001) , PACK(82918-001) , LABEL(82918-001)