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Simethicone by Cardinal Health

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 80mg
Labeler: Cardinal Health
NDC Code: 55154-8606

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Simethicone Chewable 80 mg

Active ingredient

In each tablet: Simethicone 80 mg

Purpose

Antigas

Keep Out of Reach of Children

Keep out of the reach of children.

Uses

Relieves pressure and bloating commonly referred to as gas.

Warnings

TAMPER EVIDENT: Each tablet is individually sealed. Do not use if blister or foil is broken, torn, or missing. For institutional use only. This unit dose package is not child-resistant. If dispensed for outpatient use, a child resistant container should be utilized.

Directions

Chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. Do not exceed 6 tablets per day unless directed by a physician.

Inactive ingredients

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol

STORAGE: Store at Room Temperature. Avoid high humidity and excessive heat, above 40 C (104 F)

Manufactured for

Goldline Laboratories, Inc

Sellersville, PA 18960

By Guardian Drug Company

Dayton, NJ 08810

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Simethicone Chewable Tablets

80 mg

Antigas

10 Tablets

SIMETHICONE 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-8606(NDC:0182-8643)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
DEXTROSE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
SORBITOL 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeGDC;103
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-8606-010 BLISTER PACK (BLISTER PACK) in 1 BAG
11 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/03/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 07/2011
 
Cardinal Health

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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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