babies r us childrens pain relief

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Toys"R"Us, Inc.
NDC Code: 51334-130

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. Children's Pain Relief Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

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 dosing cup designed for use with this product. Do not use any other dosing device.
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

Weight (lb)

Age (yr)

Dose (tsp or mL)

under 24

under 2 years

ask a doctor

24-35

2–3 years

1 tsp or 5 mL

36–47

4–5 years

1 1/2 tsp or 7.5 mL

48–59

6–8 years

2 tsp or 10 mL

60-71

9–10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 mL

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

Other information
each teaspoon contains: sodium 3 mg
store at 20°-25°C (68°-77°F)
do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, 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 or comments?

1-800-719-9260

Principal Display Panel

For Ages 2 - 11

Children’s Pain Relief

Acetaminophen

Oral Suspension Liquid

Fever Reducer – Pain Reliever

Aspirin Free

Ibuprofen Free

Alcohol Free

Grape Flavor

Compare to active ingredient of Children’s Tylenol® Oral Suspension

80 mg per 1/2 teaspoon (160 mg per 5 ml)

BABIES R US CHILDRENS PAIN RELIEF 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51334-130
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 
CARBOXYMETHYLCELLULOSE SODIUM 
CARRAGEENAN 
D&C RED NO. 33 
FD&C BLUE NO. 1 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
CALCIUM SULFATE 
SODIUM PHOSPHATE, TRIBASIC 
Product Characteristics
ColorPURPLE (viscous) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51334-130-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/01/2010
Labeler - Toys"R"Us, Inc. (006985808)

Revised: 01/2013
 
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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