Indications and uses
temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache temporarily reduces fever
Childrens TYLENOL
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2025-07-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:12:14
Label at a glance#
ProductChildrens TYLENOL
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
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 (table...
Storage and handling
store between 20-25°C (68-77°F). do not use if foil inner seal imprinted with "TYLENOL" is broken or missing
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each chewable tablet)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
- temporarily reduces fever
Warnings
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
Ask a doctor before use if your child has liver disease
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
When using this product
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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)
- 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
Questions or comments?
call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 313820 | acetaminophen 160 MG Chewable Tablet | PSN | 1 |
| 828557 | Tylenol Junior 160 MG Chewable Tablet | PSN | 1 |
| 828557 | acetaminophen 160 MG Chewable Tablet [Tylenol] | SBD | 1 |
| 313820 | acetaminophen 160 MG Chewable Tablet | SCD | 1 |
| 313820 | APAP 160 MG Chewable Tablet | SY | 1 |
| 828557 | APAP 160 MG Chewable Tablet [Tylenol] | SY | 1 |
| 828557 | Tylenol 160 MG Chewable Tablet | SY | 1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-517-24 | Childrens TYLENOL | 24 in 1 BOTTLE | TABLET, CHEWABLE | 24 | 1 | |
| 50580-517-24 | Childrens TYLENOL | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Childrens TYLENOL
- Acetaminophen
- ACESULFAME POTASSIUM
- ACETIC ACID
- CELLULOSE ACETATE
- ETHYL ACETATE
- MALTODEXTRIN
- MAGNESIUM STEARATE
- MANNITOL
- MICROCRYSTALLINE CELLULOSE
- POVIDONE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-517 | 50580-517-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ACETIC ACID | Q40Q9N063P | IACT |
| CELLULOSE ACETATE | 3J2P07GVB6 | IACT |
| ETHYL ACETATE | 76845O8NMZ | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Childrens TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 3a935584-6045-0a58-e063-6394a90a40c4 | 2025-07-23 | Warnings | 50580-517-24 50580-517 50580051724 3a934300-45f1-1168-e063-6394a90a9848 3a935584-6045-0a58-e063-6394a90a40c4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.