M-pap Liquid
FDA Label NDC 58657-524

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product M-pap (NDC 58657-524). 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, purpose, uses, warnings, do not use, ask a doctor before use, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use

→ Ask A Doctor Or Pharmacist Before Use

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children. Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

Other

M-PAP

Acetaminophen Liquid

160 mg/5 mL

Pain Reliever / Fever Reducer

Sugar Free / Alcohol Free

Aspirin Free

CHERRY FLAVOR

Drug Facts

Active Ingredient

(in each 5 mL teaspoonful)

Acetaminophen, USP 160 mg ....................

Purpose

Pain reliever/fever reducer

Uses

reduces fever
temporarily relieves minor aches and pains due to:
- Headache
- muscular aches
- backache
- arthritis
- the common cold
- toothache
- menstrual cramps
- reduces fever

Warnings

Liver Warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

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.

for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask A Doctor Before Use

if you have health issues especially liver disease.

Ask A Doctor Or Pharmacist Before Use

if you are taking other drugs, including the blood thinner warfarin.

Stop Use And Ask A Doctor If

new symptoms occur such as rash, hives, itching or hoarseness
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
symptoms do not improve

These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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

Directions

Do not exceed recommended dosage.

adults and children 12 years of age and older: Take 3 teaspoonfuls (15 mL) every 5 hours; do not exceed 15 teaspoonfuls (75 mL) in 24 hours

children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Other Information

each 5 mL contains: Sodium 3 mL

If dispensed, dispense in a tight, light resistant cotainer with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

Inactive Ingredients

Anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.