Label: CHILDRENS CHEWABLE 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 August 28, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Acetaminophen 80 mg

  • PURPOSE

    Purposes

    Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    Uses

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

    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

    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 DOCTOR

    Ask a doctor before use if your child has liver disease.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

  • WHEN USING

    When using this product, do not exceed recommended dose (see overdose warning)

  • STOP USE

    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

    Keep out of reach of children.

    Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • this products does not contain directions or complete warnings for adult use.
    • find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
    • chew before swallowing
    • if needed, 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.
    WeightAgeDosage
    Under 24 lbsUnder 2 yearsAsk a doctor
    24-35 lbs2-3 years2 tablets
    36-47 lbs4-5 years3 tablets
    48-59 lbs6-8 years4 tablets
    60-71 lbs9-10 years5 tablets
    72-95 lbs11 years6 tablets

  • SPL UNCLASSIFIED SECTION

    Other information

    • Phenylketonurics: Contain Phenylalanine 14 mg per tablet
    • Store at room temperature in a dry place
  • INACTIVE INGREDIENT

    Inactive ingredients Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

  • QUESTIONS

    Questions or comments?

    Call: (800) 616-2471

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    MAJOR PHARMACEUTICALS

    17177 N LAUREL PARK DRIVE, SUITE 233

    LIVONIA, MI 48152

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

  • PRINCIPAL DISPLAY PANEL

    MAJOR®
    NDC 0904-5256-46
    See New Warnings Information
    Children's Chewable
    Mapap Acetaminophen
    Fever reducer/ Pain reliever

    ASPIRIN FREE ● IBUPROFEN FREE

    NATURAL & ARTIFICIAL BERRY FLAVORS
    30 Tablets, 80 mg EACH

    AGES 2-11

    Major 0904-5256-46

  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEWABLE MAPAP 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5256
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUND (ROUND BICONVEX TABLET) Size10mm
    FlavorImprint Code 1G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5256-461 in 1 CARTON05/04/201111/30/2020
    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 finalpart34305/04/201111/30/2020
    Labeler - Major Pharmaceuticals (191427277)