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Infants Gas Relief Non-Staining Formula

Medically reviewed on December 4, 2017

Dosage form: liquid
Ingredients: Dimethicone 20mg in 0.3mL
Labeler: Walgreens
NDC Code: 0363-5345

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.

Infant's Gas Relief
Non-Staining Formula

Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Anti-gas

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.

(1-800-222-1222)

Directions
  • shake well before using
  • all doses may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day
  • only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into hole at top of bottle and turn upside down. Pull back plunger of syringe until syringe filled slightly over prescribed level. Turn to original position, simply push plunger back until you have reached the prescribe level. Pull syringe out of the bottle and dispense liquid slowly into baby's mouth, toward the inner cheek.
  • dosage can be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • for best results, clean syringe after each use and replace original cap
Age (yr)Weight (lb)Dose
infants under 2under 240.3 mL
children over 2over 240.6 mL

Other information
  • do not use if the neck wrap imprinted with "Safety Seal" is broken or missing
  • store at room temperature
    • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredients

Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Sodium Benzoate, Sodium Citrate, Sucralose

Questions or comments?

1-800-Walgreens (1-800-925-4733)

DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT ROAD
DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED

Infants'

Gas Relief

Simethicone 20 mg/Dose
Anti-Gas

  • Nonstaining formula
  • No alcohol
  • No saccharin
  • No artificial flavor
  • New dosing syringe design

100 DOSES

Compare to Infants' Mylicon®
Drops active ingredient‡‡

1 FL OZ (30 mL)

INFANTS GAS RELIEF   NON-STAINING FORMULA
dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5345
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate 
Citric Acid Monohydrate 
Hypromelloses 
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) 
Sucralose 
Vanillin 
Sodium Citrate 
Water 
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLA, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-5345-011 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 FINALpart33204/15/2013
Labeler - Walgreens (008965063)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIOperations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(0363-5345), PACK(0363-5345), LABEL(0363-5345), ANALYSIS(0363-5345)

 
Walgreens

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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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