SIMETHICONE- simethicone tablet 
Cardinal Health 107, LLC

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 Anti-Gas 80 mg Tablet

Active ingredient

Each tablet contains 80 mg Simethicone

Mint Flavored chewable tablets

Purpose

Anti-gas

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children.

Uses

Relieves pressure, bloating, and symptoms referred to as gas.

Warnings

This package is intended for institutional use only.

Do not exceed six tablets in a 24 hour period except under the advice and supervision of a physician.

In case of overdose get medical help or contact a Poison Control Center immediately.

Directions

Chew one or two tablets thoroughly as needed after meals and at bedtime.

Inactive ingredients

Compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin and sorbitol.

Storage

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

Mint Flavored chewable Tablets

Sky

Mfg. By: Guardian Drug Company

2 Charles Court

Dayton, NJ 08810

Distributed By

McKesson Packaging Services

a business unit of McKesson Corporation

7101 Weddington Road

Concord, NC 28027

Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids

www.PROmanager-Rx.com

Distributed by:

Cardinal Health

Dublin, OH 43017

L43456330318

Principal Display Panel

SIMETHICONE ANTI-GAS

80 mg TABLETS

10 TABLETS

80mg bag label
SIMETHICONE 
simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1480
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O) (DIMETHICONE, UNSPECIFIED - UNII:92RU3N3Y1O) DIMETHICONE, UNSPECIFIED80 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MAGNESIUM (UNII: I38ZP9992A)  
STEARYL STEARATE (UNII: 5WX2EGD0DK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code GDC;103
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-1480-010 in 1 BAG06/06/201103/31/2021
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 other06/06/201103/31/2021
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 11/2024
Document Id: 5360b91f-4508-4a67-aefc-207c324c9b81
Set id: d93ff75d-9cdb-476c-bb65-eabeefb91a34
Version: 6
Effective Time: 20241101
 
Cardinal Health 107, LLC