Label: CHILDRENS TYLENOL- acetaminophen suspension

  • NDC Code(s): 50580-170-01, 50580-170-02, 50580-170-03, 50580-170-04
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
      • the common cold
      • flu
      • headache
      • 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.

    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.
    • 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 do not exceed recommended dose (see overdose warning)

    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 occur
    • redness or swelling is present

    These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose warning

    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.
    • remove the child protective cap and squeeze your child's dose into the dosing cup
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
      Weight (lb)Age (yr)Dose (mL) *
      *
      or as directed by a doctor
      under 24under 2 yearsask a doctor
      24-35 lbs2-3 years5 mL
      36-47 lbs4-5 years7.5 mL
      48-59 lbs6-8 years10 mL
      60-71 lbs9-10 years12.5 mL
      72-95 lbs11 years15 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • each 5 mL contains: potassium 5 mg
    • store between 20-25°C (68-77°F)
    • do not use if carton is opened
    • do not use if bottle wrap imprinted with “TYLENOL” is broken or missing
  • Inactive ingredients

    anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

  • Questions or comments?

    call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-170-02

    Children's
    TYLENOL ®

    Acetaminophen (160 mg per 5 mL)
    Oral Suspension

    Pain Reliever-Fever Reducer

    DYE-FREE

    Pain + Fever

    Ages 2-11 Years

    Free of:

    • Dyes
    • Alcohol
    • Ibuprofen
    • Aspirin
    • Parabens
    • High Fructose

    Corn Syrup

    Cherry Flavor

    8 fl oz (240 mL)
    160 mg per 5 mL

    tylenol-01

  • INGREDIENTS AND APPEARANCE
    CHILDRENS TYLENOL 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-170
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-170-011 in 1 CARTON01/16/2017
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:50580-170-032 in 1 PACKAGE10/01/2020
    21 in 1 CARTON
    2120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    3NDC:50580-170-021 in 1 CARTON06/01/2021
    3240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    4NDC:50580-170-043 in 1 PACKAGE06/01/2021
    41 in 1 CARTON
    4120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/16/2017
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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