M-PAP ACETAMINOPHEN METHOD PHARMACEUTICALS, LLC FDA Approved Uses reduces fever temporarily relieves minor aches and pains due to: Headache muscular aches backache arthritis the common cold toothache menstrual cramps reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL teaspoonful) Acetaminophen USP 160 mg ....................
Inactive Ingredients
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.
Strengths
5 ml 160 mg
Quantities
5 ml 118 ml 473 ml
Treats Conditions
Uses Reduces Fever Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Backache Arthritis The Common Cold Toothache Menstrual Cramps Reduces Fever

Identifiers & Packaging

Container Type UNKNOWN
UPC
0358657524043
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL NDC 58657-524-04 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 4 fl. oz. (118mL) label2; PRINCIPAL DISPLAY PANEL NDC 58657-524-16 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 16 fl. oz. (473 mL) label1

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 58657-524-04 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 4 fl. oz. (118mL) label2
  • PRINCIPAL DISPLAY PANEL NDC 58657-524-16 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 16 fl. oz. (473 mL) label1

Overview

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

Indications & Usage

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

Dosage & Administration

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.

Warnings & Precautions
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. When using this product do no exceed recommended dose (see Overdose warning) 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.
Purpose

Purpose Pain reliever/fever reducer

Do Not Use

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.

When Using

When using this product do no exceed recommended dose (see Overdose warning)

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

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.

Storage & Handling

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).

Questions

Questions? 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. Distributed by: Method Pharmaceuticals Southlake, TX 76092 Rev. 02/2024


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