infants acetaminophen

Major Pharmaceuticals

Major Pharmaceuticals Infants' Acetaminophen Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 0.8 mL)
• Purpose
• infants acetaminophen Uses
• Warnings
  • Do not use
  • Ask a doctor before use
  • Ask a doctor or pharmacist before use
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• infants acetaminophen Other information
• Inactive ingredients
• Questions or comments?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Fever reducer/pain reliever

infants acetaminophen 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.

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

Directions

• 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 dropper designed for use with this product. Do not use any other dosing device.
• 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 dropper tightly to maintain child resistance
• this product does not contain directions or complete warnings for adult use

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

infants acetaminophen Other information

• store at 20°-25°C (68°-77°F)
• do not use if printed bottle wrap is broken or missing

Inactive ingredients

carboxymethylcellulose sodium, carrageenan, citric acid, glycerin, flavor, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

1-800-616-2471

Package/Label Principal Display Panel

SEE NEW WARNINGS INFORMATION

Infants’ACETAMINOPHEN

CONCENTRATED DROPS

Fever Reducer / Pain Reliever

Alcohol Free

Aspirin Free

Ibuprofen Free

DYE-FREE

CHERRY FLAVOR

Non-Staining

Compare to the active ingredient of Concentrated Tylenol® Infants' Drops

Use only with enclosed dropper

80 mg per 0.8 mL.