GAS RELIEF - dimethicone tablet, chewable
CARDINAL HEALTH

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active ingredients

Simethicone 80 mg

Purpose

Antigas

Use(s)

relieves these symptoms associated with gas

bloating
pressure
stuffed feeling
fullness

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

do not exceed 6 tablets per day unless directed by a doctor
chew 1 to 2 tablets thoroughly as needed after meals and at bedtime

Other information

store at room temperature
avoid high humidity and excessive heat, above 40ºC (104ºF)

Inactive ingredients

dextrose, peppermint flavor, silica gel, sorbitol, stearic acid, talc, tri-calcium phosphate

Principal display panel

LEADER®

NDC 37205-112-78

Compare to Mylanta® Gas active ingredient*

Simethicone 80 mg

Gas Relief

•Pressure •Bloating •Discomfort

Fast Acting

Anti Gas

Mind Flavored

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV1104E13712

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

GAS RELIEF
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-112
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (DIMETHICONE)	DIMETHICONE	80 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE
SILICON DIOXIDE
TALC

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	44;137
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37205-112-78	100 TABLET, CHEWABLE (100 TABLET) in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	07/28/1994

Labeler - CARDINAL HEALTH (097537435)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	PACK

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	MANUFACTURE

Revised: 12/2011 CARDINAL HEALTH