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Infants Gas Relief Original Formula

Medically reviewed on March 28, 2018

Dosage form: liquid
Ingredients: Dimethicone 20mg in 0.3mL
Labeler: CVS
NDC Code: 59779-701

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
Original 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
  • fill enclosed dropper to recommended dosage level 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 dropper 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 printed foil seal under cap is torn 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, Red #3, Sodium Benzoate, Sodium Citrate, Sucralose

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

CVS
pharmacy
®

Compare to the
active ingredient in
Infants' MYLICON® Drops*

Infants'
GAS
RELIEF
ORIGINAL FORMULA

SIMETHICONE/ANTIGAS

  • No alcohol
  • No saccharin
  • No artificial flavor

100 Doses
1 FL OZ (30 mL)

INFANTS GAS RELIEF   ORIGINAL FORMULA
dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-701
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 
FD&C Red No. 3 
Product Characteristics
ColorPINK (Opaque) Score    
ShapeSize
FlavorVANILLA, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-701-0136 CARTON in 1 BOX
11 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 FINALpart33201/05/2013
Labeler - CVS (062312574)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIOperations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(59779-701), PACK(59779-701), LABEL(59779-701), ANALYSIS(59779-701)

 
CVS

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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