Childrens Tylenol Suspension
FDA Label NDC 50580-612

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Childrens Tylenol (NDC 50580-612). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding childrens tylenol, active ingredient (in each tablet), purpose, uses, liver warning, other, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Childrens Tylenol

Drug Facts

Drug Facts

Active Ingredient (In Each Tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
    • temporarily reduces fever

      • temporarily:

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

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

    • 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

Other

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.

    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
    • 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

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease

Ask a doctor before use if your child has liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Otc - When Using

When using this product do not exceed recommended dose (see overdose warning)

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.

    • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.

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 below. If possible, use weight to dose; otherwise, use age.
  • chew tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
    • Weight (lb)Age (yr)Dose (tablets)

    or as directed by a doctor

    under 24under 2 yearsask a doctor
    24-352-3 years1 tablet
    36-474-5 years1½ tablets
    48-596-8 years2 tablets
    60-719-10 years2½ tablets
    72-9511 years3 tablets
    • 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
      24-352-3 years5 mL
      36-474-5 years7.5 mL
      48-596-8 years10 mL
      60-719-10 years12.5 mL
      72-9511 years15 mL

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

Other Information

  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if neck band or foil inner seal imprinted with "TYLENOL" is broken or missing
    • each 5 mL contains: sodium 2 mg
    • 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, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose

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

Questions Or Comments?

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

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

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Principal Display Panel

NDC 50580-460-01

Children's
TYLENOL®

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

Pain+Fever
Ages 2-11 Years

Ibuprofen Free
Alcohol Free
Aspirin Free

4 fl oz (120 mL)
160 mg per 5 mL
Grape
Flavor

BE READY
AT HOME
OR
ON-THE-GO

Use products only as directed.

NDC 50580-460-01

New Strength & Directions

Children's
TYLENOL®

Acetaminophen
Pain Reliever
Fever Reducer

Pain+Fever
Ages 2-11
Chewables
Ibuprofen Free, Aspirin Free

Now
160 mg
Per Tablet

24
Chewable
Tablets
Actual Size
160 mg each
Grape Flavor

Principal Display Panel (Childrenstylenol 01)

Principal Display Panel (Childrenstylenol 01)

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