SIMETHICONE- simethicone capsule, liquid filled 
ONE2ZEE LIMITED LIABILITY COMPANY

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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Extra Strength Gas Relief

Active ingredient (in each softgel)

Simethicone 125mg

Purpose

Antigas

Use

for the relief of

Warning

Keep out of reach of children.

Directions

Other Information

Inactive ingredients

FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

PRINCIPAL DISPLAY PANEL - Shipping Label

IMETHICONE CAPSULES, 325 mg

Quantity : 48 Bags of 1500 Capsules each
NDC. No : 55629-010-01

Important:

1. Inspect immediately upon receipt

2. This is bulk shipment intended for further processing only

3. store at controlled room temperature 20-25ºC (68-77ºF), protect from light, heat, and moisture

shipping label

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Povidone K30 (UNII: U725QWY32X)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize8mm
FlavorImprint Code YH3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55629-010-0148 in 1 CARTON01/19/2021
1NDC:55629-010-021500 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/19/2021
Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Establishment
NameAddressID/FEIBusiness Operations
Medgel Private Limited677385498manufacture(55629-010)

Revised: 3/2023
Document Id: 906fa458-697b-4e53-bce8-ea6cdfaaaa32
Set id: a2d1fc2d-6bb1-459d-900a-7e4f329792b1
Version: 3
Effective Time: 20230325
 
ONE2ZEE LIMITED LIABILITY COMPANY