Indications and uses
■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ temporarily reduces fever
■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ temporarily reduces fever
do not take more than directed (see overdose warning ) adults and children 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
■ store between 20-25°C (68-77°F) ■ do not use if blister unit is torn or broken
EXTRA STRENGTH TYLENOL COLD Plus FLU MULTI-SYMPTOM DAY
Active ingredients (in each caplet)
| Active ingredients (in each caplet) | Purpose |
| Acetaminophen 500 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ temporarily reduces fever
Warnings
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
Allergy alert: ccetaminophen 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.
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.
■ 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
■ liver disease
■ persistent or chronic cough such as occurs with smoking, asthma or emphysema
■ cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug
warfarin
When using this product do not exceed recommended dose
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.
If pregnant or breast-feeding, ask a health professional before use.
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.
| adults and children 12 years
and over | ■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor |
| children under 12 years | ask a doctor |
■ store between 20-25°C (68-77°F)
■
do not use if blister unit is torn or broken
carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide
call 1-877-895-3665(toll-free) or 215-273-8755(collect)
EXTRA STRENGTH TYLENOL COLD + FLU MULTI-SYMPTOM NIGHT
Active ingredients (in each caplet)
| Active ingredient (in each capsule) | Purpose |
| Acetaminophen 500 mg | Pain reliever/fever reducer |
| Chlorpheniramine maleate 2 mg | Antihistamine |
| Dextromethorphan HBr 15 mg | Cough suppressant |
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ sneezing and runny nose
■ temporarily reduces fever
Warnings
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
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.
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.
■ 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
■ 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)
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
■ 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
■ 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.
If pregnant or breast-feeding,ask a health professional before use.
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.
| adults and children
12 years and over | ■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor |
| children under 12 years | ask a doctor |
■ store between 20 - 25°C (68 - 77°F)
■
do not use if blister unit is torn or broken
carnauba wax, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
NDC 50580-585-01
Extra Strength
TYLENOL®
FOR ADULTS
COLD + FLU
MULTI-SYMPTOM
Acetaminophen,
Dextromethorphan HBr
Pain Reliever–Fever Reducer,
Cough Suppressant
DAY
• HEAD + BODY ACHES
• FEVER
• SORE THROAT
• COUGH
Actual Size
16 CAPLETS
Acetaminophen,
Chlorpheniramine Maleate,
Dextromethorphan HBr
Pain Reliever-Fever Reducer,
Antihistamine, Cough Suppressant
NIGHT
• HEAD + BODY ACHES
• FEVER • SORE THROAT
• COUGH
• RUNNY NOSE
Actual Size
8 CAPLETS
TOTAL 24 CAPLETS
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0300450159342 | GTIN-13: 0300450159342 EAN-13: 0300450159342 GTIN-12: 300450159342 UPC-A: 300450159342 GTIN storage (14 digits): 00300450159342 | tylenol-1.jpg |
| QR code link | QR Code | tylenol-1.jpg | ||
| Data code | Code 128 | 30062287 | tylenol-1.jpg |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50580-585 | 50580-585-01 |
| 50580-586 | |
| 50580-684 |
Every source-derived ingredient row is available through these pages.
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 Day Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 594f515c-b369-816d-e063-6294a90a59a1 | 2026-08-21 | Warnings | 50580-585-01 50580-585 50580058501 594f5167-2628-8160-e063-6294a90aa943 594f515c-b369-816d-e063-6294a90a59a1 |
| Extra Strength TYLENOL Cold plus Flu Multi Symptom Day | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 5487b2e1-b0e5-0236-e063-6394a90a3a8b | 2026-06-18 | Warnings | 50580-586 |
Adverse event summaries are temporarily unavailable. Other product information remains available.