Label: CHILDRENS MAPAP- acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 1, 2023

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  • Active ingredient (in each chewable tablet)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    •
    temporarily relieves minor aches and pains due to:
    o
    headache
    o
    sore throat
    o
    flu
    o
    toothache
    o
    the common cold
    •
    temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

    •
    more than 5 doses in 24 hours, which is the maximum daily amount
    •
    with other drugs containing acetaminophen

    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.
    •
    if your child is allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if your child has

    liver disease.

    Ask a doctor or pharmacist before use if your child is

    taking the blood thinning drug warfarin.

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    •
    pain gets worse or lasts more than 5 days
    •
    fever gets worse or lasts more than 3 days
    •
    new symptoms occur
    •
    redness or swelling is present

    These could be signs of a serious condition.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    this product does not contain directions or complete warnings for adult use
    •
    do not give more than directed
    •
    find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    •
    chew or crush tablets completely before swallowing; do not swallow tablets whole 
    •
    repeat dose every 4 hours while symptoms last
    •
    do not give more than 5 times in 24 hours
    •
    do not give for more than 5 days unless directed by a doctor

    Weight (lb)

    Age (yr)

    Dose (chewable tablets)*

     Under 24

     Under 2

    Ask a doctor 

    24-35

    2-3

    1 tablet

    36-47

    4-5

    1 1/2 tablets

    48-59 

    6-8

    2 tablets

    60-71

    9-10

    2 1/2 tablets

    72-95

    11

    3 tablets

    *or as directed by a doctor

  • Other information

    •
    TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    •
    avoid high humidity
    •
    store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    •
    see end flap for expiration date and lot number
  • Inactive ingredients

    citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    MAJOR®

    NDC 71205-322-24

    Children's
    Māpap®

    ACETAMINOPHEN
    160 mg Chewable Tablets
    Pain reliever / Fever reducer

    ASPIRIN FREE • IBUPROFEN FREE

    AGES
    2-11

    Chew or crush tablets completely before swallowing.

    24 Chewable Tablets,
    160 mg EACH

    Bubble Gum Flavor

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Distributed by MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152 USA M-17

    Relabeled by PROFICIENT RX LP
    Thousand Oaks, CA 91320

    Rev. 11/18
    Re-order No. 700846

    50844    REV1018B45008

    71205-322-24
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MAPAP 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-322(NDC:0904-6645)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeROUNDSize16mm
    FlavorBUBBLE GUMImprint Code 44;450
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-322-2424 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/25/2005
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-322) , RELABEL(71205-322)
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