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ED APAP (EDWARDS PHARMACEUTICALS, INC.)

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Dosage Form Package Information Links
LIQUID 236 mL in 1 BOTTLE, PLASTIC (0485-0057-08) Label Information

Complete ED APAP Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each 5mL = 1 teaspoon)

    Acetaminophen 160 mg


  • Purpose

    Pain Reliever / Fever Reducer


  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
      • the common cold
      • flu
      • headaches
      • sore throat
      • immunizations
      • toothache

  • 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 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

    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.

    When using this product

    Stop use and ask a 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. These could be signs of a serious condition.

    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
    • shake well before using
    • find right dose on chart below. If possible, use weight to dose: otherwise, use age.
    • if needed,repeat dose every 4 hours
    • do not use more than 5 times in 24 hours
    • do not give more than 5 days unless directed by a doctor.
    Weight (lbs.) Age (yrs.) Dose (tsp or mL)
    under 24 under 2 Ask a doctor
    24-35 2-3 1 tsp or 5 mL
    36-47 4-5 1 1/2 tsp or 7.5 mL
    48-59 6-8 2 tsp or 10 mL
    60-71 9-10 2 1/2 tsp or 12.5 mL
    72-95 11 3 tsp or 15 mL

  • Other information

    • Store at room temperature 15°-30° C (59°-86° F)
    • Protect from freezing
    • Protect from Light.
    • Each teaspoon (5mL) contains: sodium 7 mg

    TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING.


  • Inactive ingredients

    citric acid, FD&C red #40, flavor, glycerin, PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.


  • QUESTIONS? COMMENTS?

    Call 1-800-543-9560


  • PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

    E

    NDC 00485-0057-08

    ED-APAP
    CHILDREN'S

    ACETAMINOPHEN
    ORAL SOLUTION,
    ALCOHOL FREE
    CHERRY FLAVORED

    Contains 160 mg
    Acetaminophen in each
    teaspoon (5mL)

    8 fl oz (236 ml)

    Manufactured for:

    EDWARDS
    PHARMACEUTICALS, INC.
    111 Mulberry Street
    RIPLEY, MS 38663

    Principal Display Panel - 236 ml Bottle Label

  • INGREDIENTS AND APPEARANCE
    ED APAP 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0485-0057
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0485-0057-08 236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 03/07/2012
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)