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 April 5, 2019

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  • Active ingredient (in each chewable tablet)

    Acetaminophen 80 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

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

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  • 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  2 tablets
    36-47 4-5  3 tablets
    48-59 6-8  4 tablets
    60-71 9-10  5 tablets
    72-95  11  6 tablets

    *or as directed by a doctor

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  • 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
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  • 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

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  • Questions or comments?

    (800) 616-2471

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  • 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

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS MAPAP 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5791
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    Product Characteristics
    Color PURPLE Score no score
    Shape ROUND Size 13mm
    Flavor GRAPE Imprint Code 44;452
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5791-46 1 in 1 CARTON 12/06/2004
    1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 12/06/2004
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(0904-5791)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(0904-5791)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(0904-5791)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(0904-5791)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(0904-5791)
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