Label: TYLENOL FOR CHILDREN PLUS ADULTS- acetaminophen suspension

  • NDC Code(s): 50580-177-08
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL

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 April 14, 2021

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

  • 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
        • muscular aches
        • backache
        • minor pain of arthritis
        • premenstrual and menstrual cramps
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    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 you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if the user has liver disease

    Ask a doctor or pharmacist before use if the user 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 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • 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.

    If pregnant or breast-feeding, ask a health professional before use.

    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

    • do not give more than directed (see overdose warning)
    • shake well before using
    • mL = milliliter
    • Children 2 years to under 12 years:
      • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
      • remove the child protective cap and squeeze the dose into the dosing cup
      • repeat dose every 4 hours while symptoms last
      • do not take more than 5 times in 24 hours unless directed by a doctor
      • do not take for more than 5 days unless directed by a doctor
      Weight (lb)Age (years)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
    • Adults and children 12 years and over:
      • take 20 mL (2 × 10 mL) every 4 hours while symptoms last. For adult dosing, the dosing cup needs to be filled to 10 mL line twice.
      • do not take more than 5 doses (100 mL) in 24 hours unless directed by a doctor
      • do not take for more than 10 days unless directed by a doctor

    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 tape or 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 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-177-08
    Same as Children's TYLENOL
    with adult dosing

    TYLENOL®
    FOR CHILDREN
    + ADULTS FAMILY

    Acetaminophen (160 mg per 5 mL)
    Oral Suspension
    Pain Reliever-Fever Reducer

    DYE-FREE
    Pain+Fever

    Ages 2 Years – Adult

    FREE OF:
    Dyes
    Alcohol
    Ibuprofen
    Aspirin
    Parabens
    High Fructose
    Corn Syrup

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

    Cherry
    Flavor

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    TYLENOL FOR CHILDREN PLUS ADULTS 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-177
    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
    anhydrous citric acid (UNII: XF417D3PSL)  
    glycerin (UNII: PDC6A3C0OX)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    sorbitol solution (UNII: 8KW3E207O2)  
    sucralose (UNII: 96K6UQ3ZD4)  
    sucrose (UNII: C151H8M554)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-177-081 in 1 CARTON07/01/2021
    1240 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 not finalpart34307/01/2021
    Labeler -  Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)