BABIES R US GAS RELIEF INFANTS simethicone emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

Toys"R"Us, Inc.

INN (International Name):

DIMETHICONE

Composition:

DIMETHICONE 20 mg in 0.3 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

BABIES R US GAS RELIEF INFANTS- SIMETHICONE EMULSION
TOYS"R"US, INC.
_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._
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TOYS "R" US, INC. INFANTS' GAS RELIEF DRUG FACTS
ACTIVE INGREDIENT (IN EACH 0.3 ML)
Simethicone 20 mg
PURPOS E
Antigas
US ES
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
•
•
•
•
•
Age (yr)
Weight (lb)
Dose
infants under 2
under 24
0.3 mL
children over 2
over 24
0.6 mL
OTHER INFORMATION
•
•
INACTIVE INGREDIENTS
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
store at 20-25°C (68-77°F)
do not use if printed bottle wrap is broken or missing
anhydrous citric acid, flavor, hypromellose, maltitol solution,
purified water, simethicone emulsion,
sodium benzoate, sodium citrate, xanthan gum
QUES TIONS ?
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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:51334-8 8 2
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME