SIMETHICONE- dimethicone capsule, liquid filled 
SPIRIT PHARMACEUTICALS,LLC

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 USP 125MG

Drug Facts

Active ingredient (per softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

Warnings

Keep out of reach of children.

Directions

Other information

Inactive ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

PRINCIPAL DISPLAY PANEL - 125 mg Label

SIMETHICONE CAPSULES USP 125MG

Each Softgel Contains:
(Simethicone USP 125 mg)

LOT NO:QUANTITY:
DRUM NO:NDC NO: 68210-1901-
MFG DATE: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.

MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE           : 35916
LIC NO.                              : TN/DRUGS/00002124

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

Principal Display Panel - 125 mg Label
SIMETHICONE 
dimethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1901
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint Code P10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-1901-110 in 1 BOX
2NDC:68210-1901-230 in 1 BOX
3NDC:68210-1901-31000 in 1 BOX
4NDC:68210-1901-416000 in 1 BOX
5NDC:68210-1901-520000 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33203/01/2010
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PVT LTD675584180MANUFACTURE

Revised: 2/2010
Document Id: 76774f7e-63c1-4ce3-8e70-07bb9408b59a
Set id: 79eb60b1-f651-4f9c-8d20-a8eacfcfbbe8
Version: 1
Effective Time: 20100209
 
SPIRIT PHARMACEUTICALS,LLC