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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SIMETHICONE CAPSULES 250 mg, liquid filled

Active ingredient (in each capsule)

Simethicone 250 mg

Purpose

Anti-gas

Uses

Warnings

Stop use and ask a doctor if

condition persists

Keep out of reach of children.

Directions

Other Information

Inactive ingredients

gelatin, glycerin, sorbitol, fd&c blue no. 1, fd&c red no. 40, povidone k30, titanium dioxide, water

PRINCIPAL DISPLAY PANEL - Shipping Label

Simethicone capsules

Each Softgel Contains:
(Simethicone 250mg)

LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-017-
EXP DATE:

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.

Shipper label

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Povidone K30 (UNII: U725QWY32X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpurpleScoreno score
ShapecapsuleSize13mm
FlavorImprint Code IS9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55629-017-0148 in 1 CARTON03/02/2021
1NDC:55629-017-021500 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/02/2021
Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Establishment
NameAddressID/FEIBusiness Operations
Medgel Private Limited677385498manufacture(55629-017)

Revised: 3/2023
Document Id: 2385d841-0306-4b08-9f9d-0e66283de312
Set id: 3292fe8e-a41a-4890-baf2-575752704a48
Version: 2
Effective Time: 20230325
 
ONE2ZEE LIMITED LIABILITY COMPANY