INFANTS ANTI GAS DYE FREE- dimethicone emulsion
Western Family Foods Inc

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.

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Western Family Infants' Anti-Gas Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings

When using this product

do not exceed 12 doses per day

Keep out of reach of children.

Directions

shake well before using
all dosages may be repeated as needed, after meals and at bedtime
fill enclosed dropper to recommended dosage level
dispense liquid slowly into baby’s mouth, toward the inner cheek
may mix with 1 oz. of cool water, infant formula or other suitable liquids
clean dropper after each use and replace original cap

age (yr)	weight (lb)	dose
infants under 2	under 24	0.3 mL
children over 2	over 24	0.6 mL

Other information

store at room temperature (59°-86°F)

Inactive ingredients

citric acid, flavor, hypromellose, maltitol, methylcellulose, mono- and di- glycerides, polyethylene glycol, polyethylene glycol stearate, polysorbate 65, purified water, sodium benzoate, sodium citrate, sorbic acid, xanthan gum

Principal Display Panel

Infants' Anti-Gas

Simethicone Drops 20mg

Dye-Free

Non-Staining

No Alcohol

No Saccharin

No Artificial Flavor

No Artificial Colors

# Infant Doses {replace "#" with number of doses per package}

Compare To Infants' Mylicon® Drops Non-Staining active ingredient

Infants' Anti-Gas Carton Image 1

Infants' Anti-Gas Carton Image 2

INFANTS ANTI GAS DYE FREE
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:55312-882
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (DIMETHICONE)	DIMETHICONE	20 mg in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE
CITRIC ACID MONOHYDRATE
HYPROMELLOSES
MALTITOL
WATER
SODIUM BENZOATE
SODIUM CITRATE
SORBIC ACID
XANTHAN GUM
POLYETHYLENE GLYCOLS

Product Characteristics
Color	WHITE (white to off white, opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:55312-882-10	1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	01/15/2009

Labeler - Western Family Foods Inc (192166072)

Revised: 6/2009

Document Id: f41cfed0-2a81-49e4-ab14-e7be38bda774

Set id: f41cfed0-2a81-49e4-ab14-e7be38bda774

Version: 1

Effective Time: 20090604

Western Family Foods Inc