Label: ANTI-GAS STRIP- simethicone strip
- NDC Code(s): 82918-001-01, 82918-001-02, 82918-001-10
- Packager: Calmour
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (in each strip)
- Purpose
- Use
- Warnings
- Directions
- Other Information
-
Inactive Ingredients
Maltodextrin, Sucralose, Polyethylene Oxide, Glycerol, Magnesium Aluminometasilicate, Hypromellose, FD & C Blue 1, Cool Mint KAL 1080.
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
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 82918-001-01
ANTI-GAS STRIP
Simethicone 62.5 mg
1 STRIP
Pouch
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)
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)
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)
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INGREDIENTS AND APPEARANCE
ANTI-GAS STRIP
simethicone stripProduct 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)