SIMETHICONE- simethicone tablet, chewable 
Cardinal Health

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.

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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

bag label
SIMETHICONE 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-8606(NDC:0182-8643)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code GDC;103
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-8606-010 in 1 BAG06/03/201108/31/2011
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/03/201108/31/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-8606)

Revised: 3/2018
Document Id: f83805f1-4c44-4ee7-9a2c-1a0032d49da2
Set id: f50b167c-9ed5-4c01-ab50-d8e823d53ad3
Version: 2
Effective Time: 20180301
 
Cardinal Health