M-PAP ACETAMINOPHEN METHOD PHARMACEUTICALS, LLC FDA Approved Uses 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 Bitter Mask Cherry Flavor Citric Acid FD&C Red No. 40 Glycerin Polyethylene Glycol Purified Water Sodium Benzoate Sodium Citrate Dihydrate Sodium Saccharin Sorbitol.
Strengths
5 ml 160 mg
Quantities
5 ml 120 ml 473 ml
Treats Conditions
Uses 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
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL NDC 58657-525-04 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 4 fl. oz. (120 mL) label1; PRINCIPAL DISPLAY PANEL NDC 58657-525-16 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 16 fl. oz. (473 mL) label2

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 58657-525-04 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 4 fl. oz. (120 mL) label1
  • PRINCIPAL DISPLAY PANEL NDC 58657-525-16 M-PAP Acetaminophen Liquid 160 mg/5 mL Cherry Flavor 16 fl. oz. (473 mL) label2

Overview

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

Indications & Usage

Uses 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. Overdose Warnings: Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage. adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 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. 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. 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. 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. 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.

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. 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 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)

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. 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


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