Label: JUNIOR STRENGTH PAIN RELIEF - acetaminophen tablet

  • NDC Code(s): 66007-145-01, 66007-145-02
  • Packager: Capricorn Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/10

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

  • Active Ingredient(in each tablet)

    Acetaminophen 160mg

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  • Purpose

    Pain Reliever/Fever Reducer

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  • Uses

    temporarily relieves minor aches and pains due to:

    ■ the common cold 

    ■ flu 

    ■ headache 

    ■ temporarily  reduces fever

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  • 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.

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  • 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
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  • 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.

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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    JUNIOR STRENGTH PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66007-145
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg
    Product Characteristics
    Color purple (light purple/violet) Score 2 pieces
    Shape ROUND (Round Lozenge) Size 14mm
    Flavor GRAPE Imprint Code CP
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66007-145-02 4 in 1 CARTON
    1 NDC:66007-145-01 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 07/26/2010
    Labeler - Capricorn Pharma Inc. (041704524)
    Registrant - Capricorn Pharma Inc. (041704524)
    Establishment
    Name Address ID/FEI Business Operations
    Capricorn Pharma Inc. 041704524 manufacture
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