■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ sinus congestion and pressure ■ helps clear nasal passages ■ promotes nasal and sinus drainage ■ 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
SUDAFED® SINUS CONGESTION + COLD SEVERE DAY
Drug Facts
Active ingredients
| Active ingredients (in each tablet) | Purpose |
| Acetaminophen 500 mg | Pain reliever/fever reducer |
| Pseudoephedrine HCl 30 mg | Nasal decongestant |
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat
■ nasal congestion ■ sinus congestion and pressure
■ helps clear nasal passages
■ promotes nasal and sinus drainage
■ 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
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
taking the blood thinning drug warfarin
When using this product do not exceed recommended dose
■ nervousness, dizziness, or sleeplessness occur
■ pain or nasal congestion 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
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
candelilla wax, croscarmellose sodium, crospovidone, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose,
polyethylene glycol, povidone, pregelatinized starch, titanium dioxide, zinc stearate
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT NIGHT
Drug Facts
Active ingredients
Active ingredients (in each tablet) | Purpose |
Acetaminophen 500 mg | Pain reliever/fever reducer |
| Diphenhydramine HCl 25 mg | Antihistamine |
| Pseudoephedrine HCl 30 mg | Nasal decongestant |
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat
■ nasal congestion ■ sinus congestion and pressure
■ sneezing and runny nose
■ helps clear nasal passages ■ 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.
■ with any other product containing diphenhydramine, even one used on skin
■ 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
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
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
■ nervousness, dizziness, or sleeplessness occur
■ pain or nasal congestion 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
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
candelilla wax, croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, titanium dioxide, zinc stearate
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
NEW
NDC 50580-660-16
SUDAFED
SINUS
CONGESTION + COLD SEVERE
Acetaminophen,
Pseudoephedrine HCI,
Pain Reliever/Fever Reducer, Nasal Decongestant
DAYTIME
• SINUS PRESSURE + CONGESTION
• FEVER
• HEAD + BODY ACHES
actual size
Acetaminophen,
Diphenhydramine HCI, Pseudoephedrine HCI,
Pain Reliever/Fever Reducer, Antihistamine,
Nasal Decongestant
NIGHTTIME
• SINUS PRESSURE + CONGESTION
• FEVER
• HEAD + BODY ACHES
• RUNNY NOSE
• SNEEZING
actual size
12 TABLETS; 4 TABLETS; 16 TABLETS TOTAL
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0300450114006 | GTIN-13: 0300450114006 EAN-13: 0300450114006 GTIN-12: 300450114006 UPC-A: 300450114006 GTIN storage (14 digits): 00300450114006 | sudafed-1.jpg |
| QR code link | QR Code |  2d.kenvue.com/01/00300450114006 | sudafed-1.jpg |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50580-660 | 50580-660-16 |
| 50580-658 | |
| 50580-659 |
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 |
|---|---|---|---|---|---|---|
| Sudafed Sinus Congestion Plus Cold Severe Day | ACETAMINOPHEN, PSEUDOEPHEDRINE | Kenvue Brands LLC | 537e1a0d-820d-c3f7-e063-6294a90a56ea | 2026-06-10 | Warnings | 50580-659 |
| Sudafed Sinus Congestion plus Cold Severe Day and Night | ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE | Kenvue Brands LLC | 5382dcad-0337-4440-e063-6394a90a706e | 2026-06-10 | Warnings | 50580-660-16 50580-660 50580066016 5382e4cc-3fc5-359e-e063-6394a90a169b 5382dcad-0337-4440-e063-6394a90a706e |
Adverse event summaries are temporarily unavailable. Other product information remains available.