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equate infants gas relief

Dosage form: emulsion
Ingredients: SIMETHICONE 20mg in 0.3mL
Labeler: Raritan Pharmaceuticals Inc
NDC Code: 68163-709

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.

Equate Infants' Gas Relief Drops 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. 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
  • store at room temperature (59°-86°F)
  • 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.

Questions or comments?

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Compare to active ingredient of Mylicon® Drops

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Infants' Gas Relief

Simethicone 20 mg Drops

Safe enough to use at every feeding**

Dye Free

Non-Staining

No alcohol or saccharin

No artificial flavors

No artificial colors

**Use as directed

1 Fl. OZ (30ml)

100 Doses

Equate Infants' Gas Relief Drops

EQUATE INFANTS GAS RELIEF 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-709
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE20 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 Description
1NDC:68163-709-021 BOTTLE, DROPPER 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 - Raritan Pharmaceuticals Inc (127602287)

Revised: 06/2009
 
Raritan 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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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