Babies R Us Pain and Fever

Toys"R"Us, Inc.

Toys "R" Us, Inc. Infants' Pain & Fever Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL)
• Purpose
• Babies R Us Pain and Fever Uses
• Warnings
  • Do not use
  • Ask a doctor before use if your child has
  • Ask a doctor or pharmacist before use if your child is
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• Babies R Us Pain and Fever Other information
• Inactive ingredients
• Questions?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

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

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