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SIMETHICONE by SPIRIT PHARMACEUTICALS,LLC

Medically reviewed on December 4, 2017

Dosage form: capsule, liquid filled
Ingredients: DIMETHICONE 180mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-1902

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.

SIMETHICONE CAPSULES USP 180 MG

Drug Facts

Active ingredient (per softgel)

Simethicone 180 mg

Purpose

Antigas

Use

for the relief of

  • pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children.

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Other information
  • store at a controlled room temperature 20-25°C (68-77°F )
  • protect from heat and moisture

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"

SIMETHICONE 
dimethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1902
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
GELATIN 
TITANIUM DIOXIDE 
SORBITOL 
WATER 
HYPROMELLOSE 
FD&C YELLOW NO. 6 
PEPPERMINT OIL 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize10mm
FlavorImprint CodeP10
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-1902-11 BAG (BAG) in 1 BOX
110 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
2NDC:68210-1902-21 BAG (BAG) in 1 BOX
230 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
3NDC:68210-1902-31 BAG (BAG) in 1 BOX
31000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
4NDC:68210-1902-41 BAG (BAG) in 1 BOX
416000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
5NDC:68210-1902-51 BAG (BAG) in 1 BOX
520000 CAPSULE, LIQUID FILLED (CAPSULE) 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/FEIOperations
SOFTGEL HEALTHCARE PVT LTD675584180MANUFACTURE

 
SPIRIT PHARMACEUTICALS,LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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