Active Ingredient
(in each 5 mL teaspoonful)
Acetaminophen, USP 160 mg ....................
The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product M-pap (NDC 58657-525). 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 active ingredient, purpose, uses, warnings, ask a doctor before use, ask a doctor or pharmacist before use, do not use, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each 5 mL teaspoonful)
Acetaminophen, USP 160 mg ....................
Pain reliever/fever reducer
temporarily relieves minor aches and pains due to:
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
if you have health issues especially liver disease.
if you are taking other drugs, including the blood thinner warfarin.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
These could be signs of a serious condition.
ask a health professional before use.
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.
Do not exceed recommended dosage.
Overdose Warnings: Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.
8 teaspoonfuls (40 mL) in 24 hours
If dispensed, dispense in a tight, light resistant container 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)
Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.
1-877-250-3427 M-F (8 a.m. to 5 p.m. CST), or directly to Medwatch at 1-800-332-1088.
Serious side effects associated with use of this product may be reported to this number.
See New Warnings Information
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Distributed by:
Method Pharmaceuticals
Fort Worth, Texas 76118
Rev. 06/19
NDC 58657-525-04
M-PAP
Acetaminophen Liquid
160 mg/5 mL
Cherry Flavor
4 fl. oz. (120 mL)
NDC 58657-525-16
M-PAP
Acetaminophen Liquid
160 mg/5 mL
Cherry Flavor
16 fl. oz. (473 mL)
* Please review the disclaimer below.