INFANTS MYLICON- dimethicone suspension/ drops 
McNeil Consumer Pharmaceuticals Co.

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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Drug Facts

Active ingredients (in each 0.3mL)

Simethicone 20 mg

Purpose

Antigas

Uses

Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

Warnings

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 2Under 240.3 mL
Children over 2Over 240.6 mL

Other Information

  • do not use if printed plastic overwrap or printed neck wrap is missing or broken
  • Store between 20 - 25°C (68 - 77°F
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredients

benzoic acid, carboxymethylcellulose sodium, citric acid, D&C Red 22, D&C Red 28, flavors, glycerides (C14-18, mono- and di-), maltitol, methylcellulose, microcrystalline cellulose, polyoxyl 40 stearate, polysorbate 65, purified water, silica gel, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

Call 1-800-222-9435 (English) or 1-888-466-8746 (Spanish)

PRINCIPAL DISPLAY PANEL

NDC 16837-630-15

Infants'
MYLICON®

Simethicone-Antigas

Gas Relief

Gently breaks down
baby's gas bubbles

ORIGINAL
DROPS

#1
BRAND
RECOMMENDED BY PEDIATRICIANS
& USED BY MOMS

Safe enough to
use at every feeding*

1/2 FL OZ (15mL)

*use as directed

Principal Display Panel
INFANTS MYLICON 
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16837-630
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
benzoic acid 
carboxymethylcellulose sodium 
anhydrous citric acid 
D&C Red NO. 22 
D&C Red NO. 28 
maltitol 
cellulose, microcrystalline 
polyoxyl 40 stearate 
water 
sodium benzoate 
sodium citrate 
xanthan gum 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:16837-630-011 in 1 CARTON
130 mL in 1 BOTTLE
2NDC:16837-630-151 in 1 CARTON
215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33201/01/199010/31/2012
Labeler - McNeil Consumer Pharmaceuticals Co. (160159638)

Revised: 05/2013
Document Id: 86a8ceb6-ca78-438e-8112-ac2e95b24301
Set id: 00738f01-8010-49bd-a903-568d1b134ac0
Version: 3
Effective Time: 20130501
 
McNeil Consumer Pharmaceuticals Co.