Label: CHILDRENS MAPAP- acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated October 1, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each chewable tablet)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to:
    headache
    sore throat
    flu
    toothache
    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 not finalpart34302/25/2005
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-322) , RELABEL(71205-322)