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INFANTS MAPAP (Major Pharmaceuticals)

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SOLUTION/ DROPS 15 mL in 1 BOTTLE (0904-5901-35) Label Information

Complete INFANTS MAPAP Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each 0.8 mL)

    Acetaminophen 80 mg


  • Purpose

    Pain reliever / fever reducer


  • Uses

    temporarily:

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

  • 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 maximum daily amount
    • with other drugs containing acetaminophen.

    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 dose (see overdose warning)

    Stop use and ask a doctor if
    • pain gets worse or lasts more than 5 days
    • fever gets worse or last for 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

    Overdose warning

    Taking more than recommended dose (overdose) may cause liver damage. 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.


  • Directions

    This product does not contain directions or complete warnings for adult use.

    • USE A DOSING DEVICE to give this medicine
    • use weight, if possible, to dose; otherwise use age
    • Fill to dose level.
    • Dispense liquid slowly into child's mouth, toward inner cheek.
    • if needed, repeat dose every 4 hours while symptoms last.
    • do not give more than 5 doses in 24 hours
    • Children 2 to 3 years or 24 to 35 pounds: 2 dropperfuls (2 x 0.8 mL).
    • Children under 2 years or under 24 pounds: ask a doctor

  • Other Information

    • TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.
    • keep tightly closed
    • store at room temperature

  • Inactive Ingredients

    artificial fruit flavor, artificial orange flavor, butylparaben, citric acid, FD&C Yellow #6, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin, sodium citrate.


  • Questions?

    Adverse Drug Event Call
    (800) 616-2471


  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    NDC 0904-5901-35

    MAJOR®

    INFANTS'

    TAMPER-EVIDENT

    Māpap®

    (acetaminophen 80 mg per 0.8 mL)

    PAIN RELIEVER/
    FEVER REDUCER

    FRUIT FLAVOR

    Fast, Effective Relief
    of Infants' Fever
    and Pain

    ALCOHOL-FREE
    ASPIRIN-FREE
    IBUPROFEN-FREE

    1/2 FL OZ (15 mL)

    Compare to active ingredient of
    Infants' TYLENOL® Drops*

    Principal Display Panel - 15 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    INFANTS MAPAP   PAIN RELIEVER /FEVER REDUCER
    acetaminophen solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5901
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 80 mg  in 0.8 mL
    Inactive Ingredients
    Ingredient Name Strength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin (UNII: FST467XS7D)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    FD&C Yellow no. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color ORANGE Score     
    Shape Size
    Flavor FRUIT, ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5901-35 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 08/24/2012
    Labeler - Major Pharmaceuticals (191427277)