Label: CHILDRENS CHEWABLE 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 January 1, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Acetaminophen 80 mg

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  • PURPOSE

    Purposes

    Pain Reliever/Fever Reducer

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  • INDICATIONS & USAGE

    Uses

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

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  • 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
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  • ASK DOCTOR

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

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  • ASK DOCTOR/PHARMACIST

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

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  • WHEN USING

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

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  • 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.

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  • 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.

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  • 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.

    Weight

    Age

    Dosage

    Under 24 lbs

    Under 2 years

    Ask a doctor

    24-35 lbs

    2-3 years

    2 tablets

    36-47 lbs

    4-5 years

    3 tablets

    48-59 lbs

    6-8 years

    4 tablets

    60-71 lbs

    9-10 years

    5 tablets

    72-95 lbs

    11 years

    6 tablets

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  • SPL UNCLASSIFIED SECTION

    Other information

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

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  • QUESTIONS

    Questions or comments?

    Call: (800) 616-2471

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  • SPL UNCLASSIFIED SECTION

    Distributed by:

    MAJOR PHARMACEUTICALS

    17177 N LAUREL PARK DRIVE, SUITE 233

    LIVONIA, MI 48152

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

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

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  • PRINCIPAL DISPLAY PANEL

    MAJOR®
    NDC 63187-968-30
    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

    63187-968-30
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEWABLE MAPAP 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-968(NDC:0904-5256)
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE, UNSPECIFIED (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
    Color pink Score no score
    Shape ROUND (ROUND BICONVEX TABLET) Size 10mm
    Flavor Imprint Code 1G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63187-968-30 1 in 1 CARTON 01/01/2018
    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 05/04/2011
    Labeler - Proficient Rx LP (079196022)
    Establishment
    Name Address ID/FEI Business Operations
    Proficient Rx LP 079502574 REPACK(63187-968) , RELABEL(63187-968)
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