Indications and uses
Uses temporarily: ■ reduces fever ■ relieves minor aches and pains due to: -the common cold -flu -headache -sore throat -toothache
Uses temporarily: ■ reduces fever ■ relieves minor aches and pains due to: -the common cold -flu -headache -sore throat -toothache
Directions ■ 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. ■ push air out of syringe. Insert syringe tip into bottle opening ■ flip bottle upside down. Pull yellow part of syringe to correct dose ■ d...
Other information ■ 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
Active ingredient (in each 5 mL)
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)
■ shake well before using
■ mL = milliliter
■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.
■ push air out of syringe. Insert syringe tip into bottle opening
■ flip bottle upside down. Pull yellow part of syringe to correct dose
■ dispense liquid slowly into child’s mouth, toward inner cheek
■ repeat dose every 4 hours while symptoms last
■ do not give more than 5 times in 24 hours
■ replace cap tightly to maintain child resistance
Dosing Chart
| Weight (lb) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
* or as directed by a doctor
Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.
Other information
■ 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
anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum
Questions or comments? call
1-800-458-1635 (toll-free) or
215-273-8755 (collect)
NEW
NDC 50580-154-02
Infant's TYLENOL ®
For children
Acetaminophen (160 mg per 5 mL)
Oral Suspension
Pain Reliever-Fever Reducer
Pain+Fever
Infants
DYE-FREE
Free Of:
• Dyes
• Alcohol
• Ibuprofen
• Aspirin
• Parabens
• High Fructose Corn Syrup
• Artificial Flavoring
Natural Apple
Flavor with Other
Natural Flavors
2 fl oz (60 mL) 160 mg per 5 mL*
*Same as Children’s TYLENOL®
SimpleMeasure®
Specially designed for younger children
Use Only Enclosed Syringe
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 1 |
| 828555 | Tylenol 160 MG in 5 mL Oral Suspension | PSN | 1 |
| 828555 | acetaminophen 32 MG/ML Oral Suspension [Tylenol] | SBD | 1 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 1 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 1 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 1 |
| 828555 | APAP 32 MG/ML Oral Suspension [Tylenol] | SY | 1 |
| 828555 | Tylenol 160 MG per 5 ML Oral Suspension | SY | 1 |
| 828555 | Tylenol 32 MG/ML Oral Suspension | SY | 1 |
| 828555 | Tylenol Infants 160 MG in 5 mL Oral Suspension | SY | 1 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0300450146021 | GTIN-13: 0300450146021 EAN-13: 0300450146021 GTIN-12: 300450146021 UPC-A: 300450146021 GTIN storage (14 digits): 00300450146021 | Tylenol-1.jpg |
| QR code link | QR Code | Tylenol-1.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-154-02 | Infants TYLENOL | 60 mL in 1 BOTTLE | SUSPENSION | 60 | 1 | |
| 50580-154-02 | Infants TYLENOL | 1 in 1 CARTON | SUSPENSION | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50580-154 | 50580-154-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| Infants TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 4a121a53-dbae-05c7-e063-6294a90aed89 | 2026-02-13 | Warnings | 50580-154-02 50580-154 50580015402 4a121ba1-d91e-0039-e063-6294a90a5445 4a121a53-dbae-05c7-e063-6294a90aed89 |
Adverse event summaries are temporarily unavailable. Other product information remains available.