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 180 MG

Drug Facts

Active ingredient (per softgel)

Simethicone 180 mg

Purpose

Antigas

Use

for the relief of

Warnings

Keep out of reach of children.

Directions

Other information

Inactive ingredients

FD&C yellow 6, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE CAPSULES USP 180MG
Each Softgel Contains:

(Simethicone USP 180 mg)

LOT NO :

MFG DATE :

GROSS WT. :

NDC NO :         68210-1902
QUANTITY :

EXP DATE :

CRTN :

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 - Shipping Label
SIMETHICONE 
dimethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1902
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYPROMELLOSE (UNII: 3NXW29V3WO)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize10mm
FlavorImprint Code P10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-1902-11 in 1 BOX
110 in 1 BAG
2NDC:68210-1902-21 in 1 BOX
230 in 1 BAG
3NDC:68210-1902-31 in 1 BOX
31000 in 1 BAG
4NDC:68210-1902-41 in 1 BOX
416000 in 1 BAG
5NDC:68210-1902-51 in 1 BOX
520000 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart310.54510/01/2009
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PVT LTD675584180MANUFACTURE

Revised: 12/2009
Document Id: ff5ca266-7b84-4f5c-8618-3b08556b964e
Set id: 2700e23e-2dad-4b7d-a9e1-db21dfbf4f26
Version: 1
Effective Time: 20091202
 
SPIRIT PHARMACEUTICALS,LLC