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Infants TYLENOL (McNeil Consumer Healthcare Div. McNeil-PPC, Inc)

Available Formats

Dosage Form Package Information Links
SUSPENSION 1 BOTTLE, PLASTIC in 1 CARTON (50580-191-01) > 30 mL in 1 BOTTLE, PLASTIC Label Information

Complete Infants TYLENOL Information


    Drug Facts

  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses


    • 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. If possible, use weight to dose; otherwise, use age.
    • push air out of syringe. Insert syringe tip into bottle opening
    • flip bottle upside down. Pull yellow part of syringe to correct dose
    • dispense liquid slowly into child's mouth, toward inner cheek
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • replace cap tightly to maintain child resistance
    Dosing Chart
    Weight (lb) Age (yr) Dose (mL)*
    • or as directed by a doctor
    under 24 under 2 years ask a doctor
    24-35 2-3 years 5 mL

    Attention: use only enclosed syringe specifically designed for use with this product.

    Do not use any other dosing device.

  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if carton tape imprinted "TYLENOL" or bottle wrap imprinted "TYLENOL" is broken or missing

  • Inactive ingredients

    anhydrous citric acid, butylparaben, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

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


    NDC 50580-191-01

    For Children

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



    Ibuprofen Free
    Alcohol Free
    Aspirin Free

    See side panel for more information

    Use Only Enclosed Syringe

    1 fl oz (30 mL)
    160 mg per 5 mL

    Grape Flavor

    Principal Display Panel

    acetaminophen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-191
    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
    anhydrous citric acid (UNII: XF417D3PSL)  
    butylparaben (UNII: 3QPI1U3FV8)  
    D&C red NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C blue NO. 1 (UNII: H3R47K3TBD)  
    glycerin (UNII: PDC6A3C0OX)  
    high fructose corn syrup (UNII: XY6UN3QB6S)  
    carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-191-01 1 in 1 CARTON 05/01/2013
    1 30 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
    2 NDC:50580-191-12 1 in 1 CARTON 07/01/2014
    2 60 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/01/2013
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)