Label: ED APAP- acetaminophen liquid

  • NDC Code(s): 0485-0057-08
  • Packager: EDWARDS PHARMACEUTICALS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 10, 2023

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  • 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 24under 2Ask a doctor
    24-352-31 tsp or 5 mL
    36-474-51 1/2 tsp or 7.5 mL
    48-596-82 tsp or 10 mL
    60-719-102 1/2 tsp or 12.5 mL
    72-95113 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0485-0057-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/07/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/07/2012
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
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