Label: CHILDRENS TYLENOL- acetaminophen powder

  • NDC Code(s): 50580-555-04, 50580-555-05
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 July 9, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each powder)

    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)
    • find right dose on chart. If possible, use weight to dose; otherwise, use age.
    • tear packet and pour powder on your child's tongue
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    Weight (lb)Age (yr)Dose (powder)*
    *
    or as directed by a doctor
    under 48under 6 yearsdo not use
    48-596-8 years2 powders
    60-719-10 years2 powders
    72-9511 years3 powders
  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if packet is torn or damaged
  • Inactive ingredients

    citric acid, ethylcellulose, flavor, magnesium stearate, maltodextrin, sodium bicarbonate, sucralose, xylitol

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-555-05

    Children's
    TYLENOL®

    Acetaminophen
    Pain Reliever-Fever Reducer

    Ibuprofen Free
    Aspirin Free

    Pain+Fever Ages 6-11

    DISSOLVE PACKS

    NO WATER NEEDED
    DISSOLVES IN SECONDS
    DYE-FREE

    18 Packets*
    160 mg each packet

    Wild Berry
    Flavor
    *Packets of Powder

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    CHILDRENS TYLENOL 
    acetaminophen powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-555
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    ethylcellulose, unspecified (UNII: 7Z8S9VYZ4B)  
    magnesium stearate (UNII: 70097M6I30)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    sucralose (UNII: 96K6UQ3ZD4)  
    xylitol (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorWHITE (off white) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-555-0430 in 1 CARTON07/15/2019
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50580-555-0518 in 1 CARTON07/15/2019
    21 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34307/15/2019
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)