Your browser does not support JavaScript! LEADER INFANTS GAS RELIEF (SIMETHICONE) EMULSION [CARDINAL HEALTH]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

LEADER INFANTS GAS RELIEF (simethicone) emulsion
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • 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 after each use - replace 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 in printed seal under cap is torn or missing
  • store at room temperature
  • do not freeze
  • see bottom panel for lot and expiration date

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
 
Cardinal Health

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services