Medication Guide App

Infants Relief Non-Staining Formula

Dosage form: liquid
Ingredients: Dimethicone 410 20mg in 0.3mL
Labeler: CVS
NDC Code: 59779-102

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.

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, Sodium Benzoate, Sodium Citrate, Sucralose

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

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

CVS®
pharmacy

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

Infants'
GAS
RELIEF
NON-STAINING FORMULA

SIMETHICONE/ANTIGAS

• No alcohol
• No saccharin
• No artificial
flavor

50 Doses
0.5 FL OZ (15 mL)

INFANTS RELIEF   NON-STAINING FORMULA
dimethicone 410 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-102
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone 410 (Dimethicone 410) Dimethicone 41020 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate 
Citric Acid Monohydrate 
Hypromelloses 
Sucralose 
Vanillin 
Sodium Citrate 
Water 
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLA, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-102-051 BOTTLE, DROPPER in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33202/03/2012
Labeler - CVS (062312574)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIOperations
davAgen Pharmaceutical, LLC967545935MANUFACTURE, PACK, LABEL, ANALYSIS

Revised: 06/2012
 
CVS

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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