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.

----------

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 2 under 24 0.3 mL
children over 2 over 24 0.6 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 Type HUMAN OTC DRUG Item Code (Source) NDC:37205-119
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg  in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color WHITE (white to off white, opaque) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-119-10 1 in 1 CARTON
1 30 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 03/08/2010
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