Childrens Mapap
FDA Label NDC 76413-343

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Childrens Mapap (NDC 76413-343). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5ml), purpose, uses, liver warning, sore throat warning, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each 5ml)

→ Purpose

→ Uses

→ Liver Warning

→ Sore Throat Warning

→ Do Not Use

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 118 Ml Bottle Label

Other

Drug Facts

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Active Ingredient (In Each 5Ml)

Acetaminophen 160 mg

Purpose

Pain reliever - Fever reducer

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

with any other product 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

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 - When Using

When using this product, do not exceed recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

pain gets worse or last for 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.

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

this product does not contain directions or complete warnings for adult use
find right dose on chart. If possible, use weight to dose; otherwise, use age
mL = millileter
if needed, repeat dose every 4 hours
do not use more than 5 doses in 24 hours
use enclosed dosing cup only. Do not use any other device

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

Other Information

each 5 mL contains: sodium 1mg
TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.
store at 20° - 25°C (68° - 77°F)
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, saccharin sodium, sodium benzoate, sorbitol