MYLICON INFANTS GAS RELIEF DYE FREE- simethicone emulsion 
Infirst Healthcare

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Mylicon Infants Gas Relief Dye Free

Drug Facts

Active ingredient (in each 0.3 mL)

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.

Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

Age (yr)

Weight (lb)

Dose (mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

Other information

Inactive ingredients

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions or comments ?

Call 1-855-848-3284 toll free (English and Spanish)

Principal Display Panel

Mylicon® Infants' Drops

Simethicone-Antigas

Gas Relief

Gently breaks down baby’s gas bubbles

Dye Free Drops

Non-staining

Safe enough to use at every feeding and up to 12 times per day*

#1 Brand

Recommended by Pediatricians

Visit us at mylicon.com

No Alcohol

No Artificial Flavors

No Saccharin

Gluten Free

Safe enough to use at every feeding and up to 12 times per day*

Safe enough for even the newest of newborns

*use as directed

Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co.

Important: Keep this carton for future reference on full labeling

Manufactured for

infirst Healthcare Inc.

Westport, CT 06880

©2015 infirst Healthcare Inc.

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MYLICON INFANTS GAS RELIEF DYE FREE 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-650
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SORBITOL (UNII: 506T60A25R)  
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:62372-650-301 in 1 CARTON03/31/2015
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:62372-650-151 in 1 CARTON03/31/2015
215 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 DrugM00203/31/2015
Labeler - Infirst Healthcare (079159739)

Revised: 1/2024
Document Id: 0bb1b812-762c-9bc2-e063-6394a90a79d2
Set id: 3324139a-ed22-43af-859d-e7af19a24ee9
Version: 6
Effective Time: 20240101
 
Infirst Healthcare