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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.

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 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 well after each use – recap bottle with original cap

Age (yr)

Weight (lb)

Dose

infants under 2

under 24

0.3 mL

children over 2

over 24

0.6 mL

Other information
store at 20-25°C (68-77°F)
do not use if printed bottle wrap is broken or missing

Inactive ingredients

anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum

Questions?

1-800-719-9260

Principal Display Panel

Infants’ Gas Relief

Simethicone Drops 20 mg – Anti-Gas

Dye Free

No Alcohol

No Saccharin

No Artificial Flavor

No Artificial Colors

Non Staining Formula

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

1 fl oz (30 mL)

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 
ANHYDROUS CITRIC ACID 
HYPROMELLOSES 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBIC ACID 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off white, opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51334-882-101 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 finalpart33202/16/2011
Labeler - Toys"R"Us, Inc. (006985808)

Revised: 03/2015
 
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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