Label: ACETAMINOPHEN- acetaminophen tablet, chewable

  • 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 02/12

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

  • Active ingredient

    Acetaminophen

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  • Purpose

    Pain Reliever / Fever Reducer

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  • Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical, even if you do not notice any signs or symptoms.

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  • Uses

    temporarily reduces fever and relieves minor aches and pains caused by

    headache
    common cold
    flu
    toothache
    sore throat

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  • Warnings

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

    more than 5 doses in 24 hours, which is the maximum daily amount

    with other drugs containing acetaminophen

    Sore throat warning: If sore throat is severe, lasts for more than 2 days or is accompanied or fillowed 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.

    Ask a doctor before use if the child has liver disease

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

    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

    redness or swelling is present

    any new symptoms appear

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  • Directions

    this product does not contain directions or complete warnings for adult use

    find correct does on chart below

    if possible, use weight to dose, otherwise use age

    chew tablets before swallowing

    give dose every 4 hours while symptoms last

    do not give more than 5 doses in 24 hours

    Weight
    (pounds)
    Age
    (years)
    Dose
    (tablets)
    72 - 95 11 - 12 4 - 6
    60 - 71 9 - 10 4 - 5
    48 - 59 6 - 8 4
    36 - 47 4 - 5 3
    24 - 35 2 - 3 2
    under 24 under 2 ask a doctor
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  • Inactive ingredients
  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42254-155(NDC:0536-3233)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME  
    SUCROSE  
    D&C RED NO. 27  
    FD&C YELLOW NO. 6  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    STEARIC ACID  
    Product Characteristics
    Color PINK (Light) Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code Logo;051
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42254-155-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 02/16/2012
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    Name Address ID/FEI Business Operations
    PSS World Medical, Inc. 791528623 REPACK(42254-155)
    Establishment
    Name Address ID/FEI Business Operations
    STAT RX USA LLC 786036330 REPACK(42254-155)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 RELABEL(42254-155), REPACK(42254-155)
    Establishment
    Name Address ID/FEI Business Operations
    SCRIPT PAK 964420108 RELABEL(42254-155), REPACK(42254-155)
    Establishment
    Name Address ID/FEI Business Operations
    Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-155)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distirbutors Corp. 118802834 RELABEL(42254-155), REPACK(42254-155)
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