Infants MYLICON Dye Free

Dosage form: suspension/ drops
Ingredients: Dimethicone 20mg in 0.3mL
Labeler: Johnson & Johnson Merck Consumer Pharmaceuticals
NDC Code: 16837-911

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.

Infants'
MYLICON®
DYE FREE

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, 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 16837-911-08

Infants'
MYLICON
®

Simethicone-Antigas

Gas Relief

Gently breaks down
baby's gas bubbles

DYE FREE
DROPS

non-staining

#1
BRAND
RECOMMENDED BY PEDIATRICIANS
& USED BY MOMS

Safe enough to
use at every feeding*

1/2 FL OZ (15mL)

*use as directed

INFANTS MYLICON   DYE FREE
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16837-911
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 
maltitol 
cellulose, microcrystalline 
polyoxyl 40 stearate 
water 
sodium benzoate 
sodium citrate 
xanthan gum 
Product Characteristics
ColorWHITE (Gray- white translucent) Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:16837-911-011 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
2NDC:16837-911-062 BOTTLE (BOTTLE) in 1 PACKAGE
215 mL in 1 BOTTLE
3NDC:16837-911-081 BOTTLE (BOTTLE) in 1 CARTON
315 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33207/01/1997
Labeler - Johnson & Johnson Merck Consumer Pharmaceuticals (072217362)

Revised: 05/2011
 
Johnson & Johnson Merck Consumer Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)