children’s tylenol

children’s tylenol
SPL v1
SPL
SPL Set ID 3a935584-6045-0a58-e063-6394a90a40c4
Route
oral
Published
Effective Date 2025-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
acesulfame potassium acetic acid cellulose acetate ethyl acetate maltodextrin magnesium stearate mannitol microcrystalline cellulose povidone, unspecified sodium starch glycolate type a sucralose

Identifiers & Packaging

Pill Appearance
Imprint: TY;160;HALF;HALF Shape: round Color: white Size: 15 mm Score: 2
Marketing Status
otc monograph drug active Since 2025-09-01

Purpose

Pain reliever/fever reducer

Description

Drug Facts


Medication Information

Warnings

Warnings

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

  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (tablets)*
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 1 tablet
36-47 lbs 4-5 years 1½ tablets
48-59 lbs 6-8 years 2 tablets
60-71 lbs 9-10 years 2½ tablets
72-95 lbs 11 years 3 tablets

*or as directed by a doctor

Other Information
  • store between 20-25°C (68-77°F).
  • do not use if foil inner seal imprinted with "TYLENOL" is broken or missing
Inactive Ingredients

acesulfame potassium, acetic acid, cellulose acetate, ethyl acetate, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, povidone, sodium starch glycolate, sucralose

Description

Drug Facts

Principal Display Panel

NDC 50580-517-24

NEW

Children’s

TYLENOL®

Acetaminophen



Pain + Fever Ages 2-11 Years



Chewables

Pain Reliever

Fever Reducer

Dye-Free

Free Of:

• Dyes

• Ibuprofen

• Aspirin

• Parabens

• High Fructose Corn Syrup



Chew or crush tablets completely

before swallowing

24 Chewable Tablets

160 mg each

Actual Size



Wild Berry

Flavor

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Ask a doctor before use if your child has liver disease

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.

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

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.

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.

Questions Or Comments?

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

When Using This Product

When using this product do not exceed recommended dose

(see overdose warning)


Ask A Doctor Or Pharmacist

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

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.

Active Ingredient (in Each Chewable Tablet)

Acetaminophen 160 mg


Structured Label Content

Warnings

Warnings

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

  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (tablets)*
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 1 tablet
36-47 lbs 4-5 years 1½ tablets
48-59 lbs 6-8 years 2 tablets
60-71 lbs 9-10 years 2½ tablets
72-95 lbs 11 years 3 tablets

*or as directed by a doctor

Other Information (Other information)
  • store between 20-25°C (68-77°F).
  • do not use if foil inner seal imprinted with "TYLENOL" is broken or missing
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, acetic acid, cellulose acetate, ethyl acetate, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, povidone, sodium starch glycolate, sucralose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-517-24

NEW

Children’s

TYLENOL®

Acetaminophen



Pain + Fever Ages 2-11 Years



Chewables

Pain Reliever

Fever Reducer

Dye-Free

Free Of:

• Dyes

• Ibuprofen

• Aspirin

• Parabens

• High Fructose Corn Syrup



Chew or crush tablets completely

before swallowing

24 Chewable Tablets

160 mg each

Actual Size



Wild Berry

Flavor

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Do Not Use (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 (Ask a doctor)

Ask a doctor before use if your child has liver disease

Allergy Alert (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.

Liver Warning (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

Overdose Warning (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.

Sore Throat Warning (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.

Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)

When using this product do not exceed recommended dose

(see overdose warning)


Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

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

Stop Use and Ask A Doctor If (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.

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Acetaminophen 160 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)