Indications and uses
temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
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...
each 5 mL contains: potassium 5 mg store between 20-25°C (68-77°F) do not use if carton is opened do not use if bottle wrap imprinted with “TYLENOL” is broken or missing
Drug Facts
Acetaminophen 160 mg
Pain reliever/fever reducer
temporarily:
This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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.
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)
These could be signs of a serious condition.
Keep out of reach of children.
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.
| Weight (lb) | Age (yr) | Dose (mL) * |
|---|---|---|
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
| 36-47 lbs | 4-5 years | 7.5 mL |
| 48-59 lbs | 6-8 years | 10 mL |
| 60-71 lbs | 9-10 years | 12.5 mL |
| 72-95 lbs | 11 years | 15 mL |
* or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum
call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)
Weight (lb) Age (yr) Dose (mL) *
under 24 under 2 years ask a doctor
24-35 lb 2-3 years 5 mL
36-47 lb 4-5 years 7.5 mL
48-59 lb 6-8 years 10 mL
60-71 lb 9-10 years 12.5 mL
72-95 lb 11 years 15 mL
*or as directed by a doctor
NDC 50580-170-02
Children's
TYLENOL ®
Acetaminophen (160 mg per 5 mL)
Oral Suspension
Pain Reliever-Fever Reducer
DYE-FREE
Pain + Fever
Ages 2-11 Years
Free of:
Corn Syrup
Cherry Flavor
8 fl oz (240 mL)
160 mg per 5 mL
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 13 |
| 828555 | Tylenol 160 MG in 5 mL Oral Suspension | PSN | 13 |
| 828555 | acetaminophen 32 MG/ML Oral Suspension [Tylenol] | SBD | 13 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 13 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 13 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 13 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 13 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 13 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 13 |
| 828555 | APAP 32 MG/ML Oral Suspension [Tylenol] | SY | 13 |
| 828555 | Tylenol 160 MG per 5 ML Oral Suspension | SY | 13 |
| 828555 | Tylenol 32 MG/ML Oral Suspension | SY | 13 |
| 828555 | Tylenol Infants 160 MG in 5 mL Oral Suspension | SY | 13 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-170-01 | Childrens TYLENOL | 120 mL in 1 BOTTLE | SUSPENSION | 120 | 13 | |
| 50580-170-01 | Childrens TYLENOL | 1 in 1 CARTON | SUSPENSION | 1 | 13 | |
| 50580-170-02 | Childrens TYLENOL | 1 in 1 CARTON | SUSPENSION | 1 | 13 | |
| 50580-170-02 | Childrens TYLENOL | 240 mL in 1 BOTTLE | SUSPENSION | 240 | 13 | |
| 50580-170-03 | Childrens TYLENOL | 1 in 1 CARTON | SUSPENSION | 1 | 13 | |
| 50580-170-03 | Childrens TYLENOL | 2 in 1 PACKAGE | SUSPENSION | 2 | 13 | |
| 50580-170-04 | Childrens TYLENOL | 3 in 1 PACKAGE | SUSPENSION | 3 | 13 | |
| 50580-170-04 | Childrens TYLENOL | 1 in 1 CARTON | SUSPENSION | 1 | 13 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-170-01 | ML - Milliliter | 50580-170 | d31b3e8f-f110-461e-8a57-ba609d8e3c2b | 1 | 2017-09-11 |
| 50580-170-02 | ML - Milliliter | 50580-170 | 5a98a7a8-4b20-4581-88a6-dd1294bb44b5 | 1 | 2021-10-08 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50580-170 | 50580-170-01, 50580-170-03, 50580-170-02, 50580-170-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
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 | 46ddbfde-54ab-4373-b832-b9c0620b1e9d | 2024-11-07 | Warnings | 50580-170-01 50580-170-03 50580-170-02 50580-170-04 50580-170 50580017003 50580017001 50580017002 50580017004 21d2ce78-71b1-76a0-e063-6294a90ad014 46ddbfde-54ab-4373-b832-b9c0620b1e9d |
Adverse event summaries are temporarily unavailable. Other product information remains available.