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SIMETHICONE by SPIRIT PHARMACEUTICALS,LLC

Medically reviewed on February 9, 2018

Dosage form: capsule, liquid filled
Ingredients: DIMETHICONE 125mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-1901

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 125MG

Drug Facts

Active ingredient (per softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

  • pressure, bloating, and fullness 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 4 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 light, heat and moisture

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"

SIMETHICONE 
dimethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1901
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
GELATIN 
TITANIUM DIOXIDE 
WATER 
FD&C RED NO. 3 
PEPPERMINT OIL 
FD&C BLUE NO. 1 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint CodeP10
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-1901-110 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOX
2NDC:68210-1901-230 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOX
3NDC:68210-1901-31000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOX
4NDC:68210-1901-416000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOX
5NDC:68210-1901-520000 CAPSULE, LIQUID FILLED (CAPSULE) 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/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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