JUNIOR STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [CAPRICORN PHARMA INC.]

JUNIOR STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [CAPRICORN PHARMA INC.]
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NDC 66007-145-01, 66007-145-02
Set ID 9fa0eaa3-d9c6-45c8-9613-edf9e50021e9
Category HUMAN OTC DRUG LABEL
Packager Capricorn Pharma Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • Active Ingredient(in each tablet)

    Acetaminophen 160mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    temporarily relieves minor aches and pains due to:

    ■ the common cold 

    ■ flu 

    ■ headache 

    ■ temporarily  reduces fever

  • 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

    Do not use

    ■ with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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.

    Stop use and ask doctor if

    ■ new symptoms occur  
    ■ redness or swelling is present
    ■ pain gets worse or lasts for more than 5 days
    ■ fever gets worse or lasts for more than 3 days

    Keep out of reach of children.

    Overdose warning:

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    This product does not contain directions or complete warnings for adult use.
    Do not exceed recommended dose (see overdose warning)

    ■ find right dose on chart below. If possible, use weight to dose; otherwise, use age
    ■ dissolve in mouth or chew before swallowing
    ■ if needed, repeat dose every 4 hours
    ■ do not use more than 5 times in 24 hours

    Weight (lb)
    Under 48
    48-59
    60-71
    72-95
    96 and over
    Age (yr)
    Under 6
    6-8
    9-10
    11
    12
    Tablets
    Ask a doctor
    2
    2-1/2
    3
    4
  • Other Information

    ■ Do not use if blister unit is broken or shows signs of tampering.
    ■ Store between 20-25ºC (68-77ºF). Avoid high humidity. Protect from light.
    ■ See end panel for lot number and expiration date.

  • Inactive Ingredient

    Crospovidone, D & C red # 7, D & C red # 30, ethylcellulose, FD & C blue # 1, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, sucralose, talc, triethyl citrate

  • Principal Display Panel

    Capricorn Pharma
    ORIGINAL DEVELOPERS AND MANUFACTURERS
    Compare to the active ingredient of Junior Tylenol Meltaways
    JUNIOR STRENGTH
    Pain Relief
    ACETAMINOPHEN - 160mg each
    For Children Ages 6-11

    See new warnings information

        * Fever Reducer
        * Pain Reliever
        * Contains no Aspirin
        * Melts in your mouth

    RAPIDMELT

    24 Fast Dissolving Tablets

    Grape Flavor
    Junior strength Pain Relief Acetaminophen 160mg

  • INGREDIENTS AND APPEARANCE
    JUNIOR STRENGTH PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66007-145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
    Product Characteristics
    Colorpurple (light purple/violet) Score2 pieces
    ShapeROUND (Round Lozenge) Size14mm
    FlavorGRAPEImprint Code CP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66007-145-024 in 1 CARTON
    1NDC:66007-145-016 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/26/2010
    Labeler - Capricorn Pharma Inc. (041704524)
    Registrant - Capricorn Pharma Inc. (041704524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Capricorn Pharma Inc.041704524manufacture

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