Label: CHILDRENS MAPAP- acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 April 8, 2021

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  • Active ingredient (in each chewable tablet)

    Acetaminophen 80 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • toothache
      • sore throat
      • the common cold
      • flu
    • 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 24Under 2Ask a doctor
    24-352-32 tablets
    36-474-53 tablets
    48-596-84 tablets
    60-719-105 tablets
    72-95116 tablets

    *or as directed by a doctor

  • Other information

    • 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, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    MAJOR®

    NDC 0904-5791-46

    Children's
    Māpap®

    ACETAMINOPHEN
    80 mg Chewable Tablets
    Pain reliever / Fever reducer

    ASPIRIN FREE • IBUPROFEN FREE

    AGES 2-6

    30 Chewable Tablets

    Chew or crush
    tablets completely
    before swallowing.

    Grape Flavor

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    50844      REV0119H45201

    Distributed by MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152 USA        M-17       Rev. 02/19
    Re-order No. 006446

    Major 44-452

    Major 44-452

  • INGREDIENTS AND APPEARANCE
    CHILDRENS MAPAP 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5791
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize13mm
    FlavorGRAPEImprint Code 44;452
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5791-461 in 1 CARTON12/06/2004
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/06/2004
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0904-5791)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0904-5791)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0904-5791)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0904-5791)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0904-5791)
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