INFANTS MAPAP

Major Pharmaceuticals

INFANTS' MAPAP Pain Reliever /Fever Reducer

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 0.8 mL)
• Purpose
• INFANTS MAPAP Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Do not use
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• Other Information
• Inactive Ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Pain reliever / fever reducer

INFANTS MAPAP Uses

temporarily:

• reduces fever
• relieves minor aches and pains due to:
  • 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 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 is allergic to acetaminophen or any of the inactive ingredients in this product.

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 last for 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 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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions

This product does not contain directions or complete warnings for adult use.

• USE A DOSING DEVICE to give this medicine
• use weight, if possible, to dose; otherwise use age
• 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 doses in 24 hours
• Children 2 to 3 years or 24 to 35 pounds: 2 dropperfuls (2 x 0.8 mL).
• Children under 2 years or under 24 pounds: ask a doctor

Other Information

• TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.
• keep tightly closed
• store at room temperature

Inactive Ingredients

artificial fruit flavor, artificial orange flavor, butylparaben, citric acid, FD&C Yellow #6, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin, sodium citrate.

Questions?

Adverse Drug Event Call
(800) 616-2471

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

NDC 0904-5901-35

MAJOR^®

INFANTS'

TAMPER-EVIDENT

Māpap ^®

(acetaminophen 80 mg per 0.8 mL)

PAIN RELIEVER/
FEVER REDUCER

FRUIT FLAVOR

Fast, Effective Relief
of Infants' Fever
and Pain

ALCOHOL-FREE
ASPIRIN-FREE
IBUPROFEN-FREE

1/2 FL OZ (15 mL)

Compare to active ingredient of
Infants' TYLENOL^® Drops*