Label: ACETAMINOPHEN - acetaminophen tablet

  • NDC Code(s): 0536-3233-07
  • Packager: Rugby Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 10, 2012

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

  • Active Ingredient

    (in each tablet)

    Acetaminophen 80 mg

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  • Purpose

    Pain Reliever/Fever Reducer

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  • Uses

    For the temporary relief of minor aches and pains due to:

    • common cold
    • flu
    • headache
    • sore throat
    • toothache
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  • WARNINGS

    This product contains acetaminophen. Severe liver damage may occur if your child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
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  • 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.

    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 a doctor if

    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • new symptoms appear
    • redness or swelling is present

    These could be signs of a serious condition.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
    • find correct dose 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 Age Dose
    72 - 95 lbs 11-12 years 4 – 6 tablets
    60 - 71 lbs 9 - 10 years 4 – 5 tablets
    48 - 59 lbs 6 - 8 years 4 tablets
    36 - 47 lbs 4 - 5 years 3 tablets
    24 - 35 lbs 2 - 3 years 2 tablets
    under 24 lbs under 2 years ask a doctor
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  • Other Information

    • store at room temperature 15°-30°C (59°-86°F)
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  • Inactive Ingredients

    citric acid, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose syrup

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  • Questions or Comments

    Call 1-800-645-2158

    Children's Pain & Fever is manufactured for Rugby Laboratories, Inc.

    Duluth, Georgia 30097

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    C:\Users\advance\Pictures\rugby_apap.jpg

    18 mL Bottle Carton

    ASPIRIN FREE

    NDC 0536-3233-07

    Rugby

    RELIEVES
    CHILDREN’S
    Pain
    & Fever
    ACETAMINOPHEN
    Chewable Tablets
    FRUIT FLAVORED
    Pain Reliever
    Fever Reducer

    30 Tablets

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3233
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color PINK (Light Pink) Score 2 pieces
    Shape ROUND Size 10mm
    Flavor FRUIT (fruit flavor) Imprint Code AP;051
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-3233-07 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 08/12/2002
    Labeler - Rugby Laboratories Inc. (191427277)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 MANUFACTURE(0536-3233)
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