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INFANTS GAS RELIEF

Dosage form: suspension/ drops
Ingredients: DIMETHICONE 20mg in 0.3mL
Labeler: MAJOR Pharmaceuticals Inc.
NDC Code: 0904-5894

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.

Active ingredient (in each 0.3 mL)Simethicone 20 mg

Purpose

Antigas

Userelieves the symptoms referred to as gas

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 inner cheek
  • dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper well after each use and replace original cap

Age (years)Weight (lbs) Dose
infants (under 2)
under 24
0.3 mL
children (2 and over)
24 and over
0.6 mL

Other information
  •  TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing.
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, maltitol, microcrystalline cellulose, flavor, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions?

Adverse Drug Event Call:(800)616-2471

package Label

NDC 00904-5894-30

MAJOR

INFANTS' GAS RELIEF DROPS

Simethicone Oral Suspension USP

Anti gas
relieves the symptoms referred to as gas
dye free
plastic dropper enclosed
compare to active ingredient in MYLICON infants drops*

1 FL OZ (30 mL)


INFANTS GAS RELIEF  
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5894
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 
MALTITOL 
CELLULOSE, MICROCRYSTALLINE 
WATER 
SODIUM BENZOATE 
ANHYDROUS TRISODIUM CITRATE 
XANTHAN GUM 
Product Characteristics
Colorwhite (off-white) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5894-301 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33212/07/2010
Labeler - MAJOR Pharmaceuticals Inc. (191427277)
Registrant - GCP Laboratories (965480861)

Revised: 06/2012
Document Id: 57565059-8150-4537-88b6-bb8758ab49a0
Set id: b58e668f-6415-4ce0-b935-822abfd28932
Version: 1
Effective Time: 20120628
 
MAJOR Pharmaceuticals Inc.

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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