FDA Label for Childrens Mapap Acetaminophen

Other

Drug Facts

Active Ingredient(In Each Tsp (5 Ml))

Acetaminophen 160 mg

Purpose

Fever reducer-Pain reliever

Uses

Temporarily relieves minor aches and pains due to:

• •the common cold
• •flu
• •headache
• •sore throat
• •toothache

Temporarily reduces fever

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

• 1.with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

Otc - Stop Use

Stop use and ask a doctor if

• 1.pain gets worse or last for more than 5 days
• 2.fever gets worse or last for more than 3 days
• 3.new symptoms occur
• 4.redness or swelling is present

These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of the 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• 1.this product does not contain directions or complete warnings for adult use
• 2.find right dose on chart
• 3.if possible, use weight to dose; otherwise, use age
• 4.if needed, repeat dose every 4 hours
• 5.do not use more than 5 doses in 24 hours

Weight	Age	Dose
under 24 lbs	Under 2 years	ask a doctor
24 to 35 lbs	2 to 3 years	1 TSP (5 mL)
36 to 47 lbs	4 to 5 years	1 1/2 TSP (7.5 mL)
48 to 59 lbs	6 to 8 years	2 TSP (10 mL)
60 to 71 lbs	9 to 10 years	2 1/2 TSP (12.5 mL)
72 to 95 lbs	11 years	3 TSP (15 mL)

Other Information

• 1.Each TSP(5 mL) contains: sodium 1mg
• 2.TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.
• 3.store at 20° - 25°C (68° – 77°F)
• 4.this product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

Inactive Ingredients

artificial flavor, citric acid anhydrous, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sodium saccharin,sorbitol

Questions?

To Report Adverse Drug Event call 1-800-616-2471 Weekdays, 9AM - 5PM Eastern Time

Principal Display Panel - 118Ml Bottle Carton

NDC 63187-588-04
TAMPER EVIDENT

MAJOR^®

Children's
FEVER REDUCER-PAIN RELIEVER
Māpap^®
ACETAMINOPHEN LIQUID

Fast, Effective Relief
of Children's
Fever and Pain

• 1.Alcohol Free
• 2.Aspirin Free
• 3.Cherry Flavor

See New Warnings Information

COMPARE TO the active
ingredient of TYLENOL®* LIQUID

4 Fl. OZ. (118mL)
80 mg per 1/2 teaspoonful (160 mg per 5 mL)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

63187-588-04 - childrensmapap 01