babies r us gas relief infants

Dosage form: emulsion
Ingredients: DIMETHICONE 20mg in 0.3mL
Labeler: Toys"R"Us, Inc.
NDC Code: 51334-882

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.

Toys "R" Us, Inc. Infants' Gas Relief Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings

When using this product

do not exceed 12 doses per day

Keep out of reach of children.

Directions
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommended dosage level
  • dispense liquid slowly into baby’s mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • 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

store at room temperature (59°-86°F)

Inactive ingredients

citric acid, flavor, hypromellose, maltitol, methylcellulose, mono- and di- glycerides, polyethylene glycol, polyethylene glycol stearate, polysorbate 65, purified water, sodium benzoate, sodium citrate, sorbic acid, xanthan gum

Questions or comments? 1-800-719-9260

Principal Display Panel

Infants' Gas Relief

Simethicone Drops

Simethicone 20 mg - Anti-Gas

No Alcohol

No Saccharin

No Artificial Flavor

No Artificial Colors

Non Staining Formula

Compare to the active ingredient of Infants' Mylicon® Drops Non-Staining

Infants' Gas Relief Carton Image 1

Infants' Gas Relief Carton Image 2

BABIES R US GAS RELIEF  INFANTS
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51334-882
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CITRIC ACID MONOHYDRATE 
HYPROMELLOSES 
MALTITOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBIC ACID 
XANTHAN GUM 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorWHITE (white to off white, opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51334-882-101 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 finalpart33202/16/2011
Labeler - Toys"R"Us, Inc. (006985808)

Revised: 02/2011
 
Toys"R"Us, 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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