Label: M-PAP- acetaminophen liquid

  • NDC Code(s): 58657-524-04, 58657-524-16
  • Packager: Method Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2024

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  • SPL UNCLASSIFIED SECTION

    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.

    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.

  • 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.

  • 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

  • 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

  • INGREDIENTS AND APPEARANCE
    M-PAP 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-524
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-524-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2024
    2NDC:58657-524-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/01/2023
    Labeler - Method Pharmaceuticals, LLC (060216698)
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