MAPAP TABLET [DIRECTRX]

MAPAP TABLET [DIRECTRX]
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NDC 61919-875-71
Set ID 87d6ce0b-19da-84e0-e053-2a95a90a0090
Category HUMAN OTC DRUG LABEL
Packager DirectRX
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION


    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • PURPOSE

    Purposes

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    for the temporary relief of minor aches and pains due to:
    headache
    muscular aches
    backache
    minor pain of arthritis
    the common cold
    toothache
    premenstrual and menstrual cramps
    temporarily reduces fever

  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    adult takes more than 4,000 mg in 24 hours
    child takes more than 5 doses in 24 hours, which is the maximum daily amount
    taken with other drugs containing acetaminophen
    adult has 3 or more alcoholic drinks every day while using this product

    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.

    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 you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if the user has liver disease.

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    pain gets worse or lasts more than 10 days in adults
    pain gets worse or lasts more than 5 days in children under 12 years
    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.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than directed (see overdose warning)

    AGE DOSE
    Adults and children 12 years and over

    take 2 tablets every 4 to 6 hours while symptoms last
    do not take more than 10 tablets in 24 hours, unless directed by a doctor
    do not use for more than 10 days unless directed by a doctor

    Children 6 years to under 12 years

    take 1 tablet every 4 to 6 hours while symptoms last
    do not take more than 5 tablets in 24 hours
    do not use for more than 5 days unless directed by a doctor

    Children under 6 years ask a doctor

  • STORAGE AND HANDLING

    Other information

    Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • QUESTIONS


    Questions or comments?Call (800) 616-2471

  • OTHER SAFETY INFORMATION


    Do not use if imprinted Safety Seal under cap is broken or missing

  • SPL UNCLASSIFIED SECTION

    Distributed By: MAJOR® PHARMACEUTICALS

    17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    875-71

  • INGREDIENTS AND APPEARANCE
    MAPAP 
    mapap tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-875(NDC:0904-1982)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K12 (UNII: 333AG72FWJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (flat faced beveled edge) Size10mm
    FlavorImprint Code GPI;A325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-875-71100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/01/2019
    Labeler - DirectRX (079254320)
    Registrant - DirectRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRX079254320repack(61919-875)

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