Infants' TYLENOL®

Infants' TYLENOL®

Drug Labeling and Warnings

Drug Details

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INFANTS TYLENOL- acetaminophen suspension 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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.

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Infants' TYLENOL®

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. 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 24under 2 yearsask a doctor
    24-352-3 years5 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, 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: 50580-599-01

    Infants'
    Tylenol
    ®
    For Children

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

    Pain + Fever

    Infants

    Dye-Free

    Ibuprofen Free

    Alcohol Free

    Aspirin Free

    Cherry Flavor

    SimpleMeasure®
    See label booklet for more information

    2 fl oz (60 mL)
    160 mg per 5 mL

    Use Only Enclosed Syringe

    Principal Display Panel
    INFANTS TYLENOL 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50580-599
    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 form (UNII: K679OBS311)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    sucrose (UNII: C151H8M554)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (Dye Free) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 50580-599-011 in 1 CARTON06/26/2017
    160 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 FINALpart34306/26/2017
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

    Revised: 11/2017
     
    Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division


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