careone infants pain relief

American Sales Company

American Sales Company Infants’ Pain Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL)
• Purpose
• careone infants pain relief 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
  • When using this product
  • Stop use and ask a doctor if
• Keep out of reach of children.
• Directions
  • careone infants pain relief Other information
• Inactive ingredients
  • Questions or comments?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

careone infants pain relief 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

When using this product

do not exceed recommended dose (see overdose warning)

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 overdose warning)
• •shake well before using
• •mL = milliliter
• •find right dose on chart. If possible, use weight to dose; otherwise, use age.
• •push air out of syringe. Firmly push syringe into bottle opening.
• •turn bottle upside down. Pull syringe to the first dose line and then push product back into bottle.
• •pull syringe until it reaches and stays at the correct dose
• •dispense liquid slowly into child’s mouth, toward inner cheek
• •repeat dose every 4 hours while symptoms last
• •do not give more than 5 times in 24 hours
• •replace cap tightly to maintain child resistance

Dosing Chart

*or as directed by a doctor

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 neckband is broken or missing

Inactive ingredients

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

1-800-719-9260

Package/Label Principal Display Panel

Compare to the Active Ingredient in Infants’ Tylenol® Oral Suspension

INFANTS’

PAIN RELIEF

Fever Reducer-Pain Reliever

Acetaminophen

Suspension Liquid

BUBBLE GUM FLAVOR

Alcohol Free – Aspirin Free

Ibuprofen Free

See side panel for more information

Use only with enclosed syringe

SEE NEW DOSAGE & DIRECTIONS

2 FL OZ (59 mL)

160 mg per 5 mL