Simethicone by Cardinal Health SIMETHICONE tablet

Simethicone by

Drug Labeling and Warnings

Simethicone by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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)