Indications and uses
■ temporarily relieves these common cold/flu symptoms ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ sneezing and runny nose ■ temporarily reduces fever
Extra Strength Tylenol Cold + Flu Multi-Symptom Nighttime
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2026-05-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-06-03 18:04:06
Label at a glance#
ProductExtra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime
Active ingredientDOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed (see overdose warning ) shake well before using mL = milliliter use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 30 mL in the dosing cup provided every 6 hours while symptoms last do not take more than 90 mL in 24 hours, unless directed by a doctor do not use for more than 10 days unless di...
Storage and handling
each 30 mL contains: sodium 19 mg store between 20-25°C (68-77°F) do not use if neck band imprinted with “INSTANT COOLING SENSATION” or foil inner seal imprinted with “TYLENOL” is broken or missing
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
Active ingredients (in each 30 mL) | Purpose |
| Acetaminophen 1000 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 30 mg | Cough suppressant |
| Doxylamine succinate 12.5 mg | Antihistamine |
Uses
■ temporarily relieves these common cold/flu symptoms
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ sneezing and runny nose
■ temporarily reduces fever
Warnings
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
SPL UNCLASSIFIED SECTION
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 you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
■ liver disease
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma
■ trouble urinating due to an enlarged prostate gland
■ persistent or chronic cough such as occurs with smoking, asthma or emphysema
■ cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
■ do not exceed recommended dose
■
excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ avoid alcoholic drinks
■ be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
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
- do not take more than directed (see overdose warning)
- shake well before using
- mL = milliliter
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults and children 12 years and over |
|
children under 12 years |
|
Other information
- each 30 mL contains: sodium 19 mg
- store between 20-25°C (68-77°F)
- do not use if neck band imprinted with “INSTANT COOLING SENSATION” or foil inner seal imprinted with “TYLENOL” is broken or missing
Inactive ingredients
anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose
and carboxymethylcellulose sodium, poloxamer, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose
Questions or comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
NDC 50580-212-01
Extra Strength
TYLENOL
®
FOR ADULTS
COLD + FLU
MULTI-SYMPTOM
Acetaminophen,Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever-Fever Reducer, Cough Suppressant, Antihistamine
NIGHT
• HEAD + BODY ACHES
• FEVER • SORE THROAT
• COUGH • SNEEZING
• RUNNY NOSE
FROSTED BERRY
8 fl oz
(240 mL)
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0300450522092 | GTIN-13: 0300450522092 EAN-13: 0300450522092 GTIN-12: 300450522092 UPC-A: 300450522092 GTIN storage (14 digits): 00300450522092 | Tylenol-1.jpg |
| QR code link | QR Code |  2d.kenvue.com/01/00300450522092 | Tylenol-1.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- SUCRALOSE
- SORBITOL
- GLYCERIN
- ANHYDROUS CITRIC ACID
- CARBOXYMETHYLCELLULOSE SODIUM
- FD&C RED NO. 40
- MICROCRYSTALLINE CELLULOSE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- POLOXAMER 188
- POLYETHYLENE GLYCOL, UNSPECIFIED
- FD&C BLUE NO. 1
- ACETAMINOPHEN
- SODIUM BENZOATE
- PROPYLENE GLYCOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-212 | 50580-212-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 525467fb-510d-0b4b-e063-6294a90acd36 | 2026-05-21 | Warnings | 50580-212-01 50580-212 50580021201 5254872f-1467-509b-e063-6394a90a7d81 525467fb-510d-0b4b-e063-6294a90acd36 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.