Label: ACETAMINOPHEN suspension

  • NDC Code(s): 63868-678-60
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 26, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient                         Purpose(in each 5 mL)

    Acetaminophen 160 mg ............... Pain reliever/fever reducer

  • PURPOSE

    • Pain reliever
    • fever reducer
  • Uses temporarily:

    • reduces fever
    • relieves minor aches and pains

    due to:


    • the common cold
    • headache
    • flu
    • sore throat
    • 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

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening 
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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.

    When using this product do not exceed recommended dose (see overdose warning)

  • 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 DOCTOR

    Ask a doctor before use if your child has liver disease

  • ASK DOCTOR/PHARMACIST

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

  • Stop use and ask a doctor if

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

    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    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 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use. 
    • do not give more than directed (see overdose warning)
    • shake well before using
    • ml= milliliter
    • find right dose on chart below.

    If possible, use weight to dose; otherwise, use age.

    • only use enclosed measuring syringe
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
      *
      or as directed by doctor

      Weight (Ib)

      Age (yr)

      Dose (mL)*

      Under 24

      Under 2 years

      Ask a doctor

      24-35

      2-3 years

      5 mL

  • Other information

    • store between 20° -25°c (68°-77 °F)
    • protect from freezing
    • protect from light

    Questions or comments?
    1-800-935-2362 (Mon-Fri 9am-5pm EST)

  • Inactive ingredients

    acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum

  • SPL UNCLASSIFIED SECTION

    "This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Tylenol®

    Distributed by C.D.M.A. lnc.
    43157 W 9 Mile Rd
    Novi, MI 48375
    www.qualitychoice.com
    Question: 800-935-2362

  • PRINCIPAL DISPLAY PANEL

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-678
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-678-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/01/2021
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Registrant - Seaway Pharma Inc. (117218785)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seaway Pharma Inc.117218785manufacture(63868-678)