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Acetaminophen (Rugby Laboratories Inc.)

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TABLET 30 TABLET in 1 BOTTLE (0536-3233-07) Label Information

Complete Acetaminophen Information

  • Active Ingredient

    (in each tablet)

    Acetaminophen 80 mg


  • Purpose

    Pain Reliever/Fever Reducer


  • Uses

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

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

  • 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

  • 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.


  • 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

  • Other Information

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

  • 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


  • Questions or Comments

    Call 1-800-645-2158

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

    Duluth, Georgia 30097


  • 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


  • 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)