LEADER INFANTS GAS RELIEF- dimethicone emulsion 
Cardinal Health

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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Leader Infants Gas Relief Drops

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. In case of overdose get medical help or contact a poison control center right away.

Directions

age (yr)weight (lb)dose
infants under 2under 240.3 mL
children over 2over 240.6 mL

Other information

Inactive ingredients

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, PEG-40 monostearate, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol.

Principal Display Panel

Compare to Infants' Mylicon Drops active ingredient

Infants' Gas Relief Drops

Anti-gas/Simethicone

Non-Staining

suitable for infant use

no artificial colors

no saccharin

alcohol free

1 Fl. OZ (30ml)

Leader Infants' Gas Relief
LEADER INFANTS GAS RELIEF 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-119
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
ANHYDROUS CITRIC ACID 
CELLULOSE, MICROCRYSTALLINE 
PEG-40 STEARATE 
POTASSIUM SORBATE 
WATER 
SODIUM BENZOATE 
SORBITAN MONOSTEARATE 
SORBITOL 
Product Characteristics
ColorWHITE (white to off white, opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-119-101 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/08/2010
Labeler - Cardinal Health (097537435)

Revised: 6/2009
Document Id: 41936f0b-c098-4958-83c7-35a664034930
Set id: 41936f0b-c098-4958-83c7-35a664034930
Version: 1
Effective Time: 20090604
 
Cardinal Health