Your browser does not support JavaScript! BABIES R US PAIN AND FEVER (ACETAMINOPHEN) LIQUID [TOYS"R"US, INC.]
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RxNorm Names

BABIES R US PAIN AND FEVER (acetaminophen) liquid
[Toys"R"Us, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Fever reducer/pain reliever

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
the common cold
flu
headache
sore throat
toothache

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

liver disease

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

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) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

this product does not contain directions or complete warnings for adult use
do not give more than directed (see Liver warning)
shake well before using
find right dose on chart. If possible, use weight to dose; otherwise use age.
use only enclosed syringe designed for use with this product. Do not use any other dosing device.
remove bottle cap and insert syringe tip through opening at top of the bottle
tip the bottle upside down and draw medicine into the syringe
fill to dose level
dispense liquid slowly into child’s mouth, toward inner cheek
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give for more than 5 days unless directed by a doctor
replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

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, butylparaben, calcium sulfate, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions?

1-800-719-9260

Package/Label Principal Display Panel

Infants’

Pain & Fever

Acetaminophen - Suspension Liquid

Fever Reducer – Pain Reliever

Aspirin Free

Ibuprofen Free

Alcohol Free

Cherry Flavor

Use only with enclosed syringe

See New Dosage & Directions

Pediatrician Preferred Dosing System

Compare to the active ingredient of Infants' Tylenol® Suspension Liquid

160 mg per 5 ml

Infants' Pain & Fever Carton Image 1

Infants' Pain & Fever Carton Image 1

Infants' Pain & Fever Carton Image 2

Infants' Pain & Fever Carton Image 2

BABIES R US PAIN AND FEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51334-161
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
CALCIUM SULFATE 
CARRAGEENAN 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SODIUM PHOSPHATE, TRIBASIC 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51334-161-101 in 1 CARTON
130 mL in 1 BOTTLE
2NDC:51334-161-161 in 1 CARTON
260 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/29/2011
Labeler - Toys"R"Us, Inc. (006985808)

Revised: 9/2012
 
Toys"R"Us, Inc.

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