ANTI-GAS STRIP - simethicone strip 
Calmour

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient (in each strip)

Simethicone 62.5 mg

Purpose

Antigas

Use

For the relief of

Warnings

Directions

Other Information

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

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

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

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)

Carton
ANTI-GAS STRIP 
simethicone strip
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82918-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE62.5 mg
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82918-001-1010 in 1 CARTON07/20/2023
1NDC:82918-001-0110 in 1 CARTON
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:82918-001-0230 in 1 CARTON07/20/2023
21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/20/2023
Labeler - Calmour (118597110)
Registrant - Shilpa Medicare Limited, Unit-VI (854193706)
Establishment
NameAddressID/FEIBusiness Operations
Shilpa Medicare Limited, Unit-VI854193706ANALYSIS(82918-001) , MANUFACTURE(82918-001) , PACK(82918-001) , LABEL(82918-001)

Revised: 7/2023
Document Id: 7a9af416-2a5d-494a-9bb4-5df28273b374
Set id: c1576ee9-69ff-41ff-b2d0-7703c8fa8edd
Version: 3
Effective Time: 20230720
 
Calmour