SIMETHICONE- simethicone tablet 
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 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

bag label
SIMETHICONE 
simethicone tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-1480(NDC:63739-225)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE (UNII: C151H8M554)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MAGNESIUM (UNII: I38ZP9992A)  
STEARYL STEARATE (UNII: 5WX2EGD0DK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code GDC;103
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-1480-0 10 in 1 BAG 06/06/2011
1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/06/2011
Labeler - Cardinal Health (603638201)

Revised: 12/2018
Document Id: 6502ddbc-d20e-466c-b06e-44d649bd6c6d
Set id: d93ff75d-9cdb-476c-bb65-eabeefb91a34
Version: 5
Effective Time: 20181221
 
Cardinal Health