INFANTS ANTI GAS DYE FREE- simethicone 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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

shake well before using
all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.
fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
clean dropper well after each use – recap bottle with 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 20-25°C (68-77°F)
do not use if printed bottle wrap is broken or missing

Inactive ingredients

anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum

Principal Display Panel

Infants’ Anti-Gas

SIMETHICONE DROPS 20mg

DYE FREE

NON-STAINING

Gently Breaks Down Baby’s Gas Bubbles

Safe Enough to use at Every Feeding**

**use as directed

1 FL OZ (30mL)

Pediatrician Recommended #1 Active Ingredient

COMPARE TO INFANTS’ MYLICON® DROPS NON-STAINING active ingredient

Western Family Infants' Anti-Gas Image 1
Western Family Infants' Anti-Gas Image 2
INFANTS ANTI GAS  DYE FREE
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-882
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBIC ACID (UNII: X045WJ989B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (white to off white, opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-882-101 in 1 CARTON01/15/200907/27/2017
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/15/200907/27/2017
Labeler - Western Family Foods Inc (192166072)

Revised: 11/2017
 
Western Family Foods Inc