Indications and uses
temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2025-07-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:08:04
Label at a glance#
ProductEXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure9 sections
Dosage and administration
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
Storage and handling
store between 20 - 25°C (68 - 77°F). do not use if blister unit is torn or broken
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough
- temporarily reduces fever
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
■ 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
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.
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)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Other information
- store between 20 - 25°C (68 - 77°F).
- do not use if blister unit is torn or broken
Inactive ingredients
carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide
Questions or comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
NDC 50580-446-01
EXTRA STRENGTH
TYLENOL
®
FOR ADULTS
SEVERE COUGH
+ SORE THROAT
NEW!
DOSAGE + DIRECTIONS
Acetaminophen,
Dextromethorphan HBr
Pain Reliever-Fever Reducer,
Cough Suppressant
DAY
• HEAD + BODY ACHES
• FEVER + SORE THROAT
• COUGH
Actual Size
24 CAPLETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 247324 | acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet | PSN | 5 |
| 247324 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet | SCD | 5 |
| 247324 | acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet | SY | 5 |
| 247324 | APAP 500 MG / Dextromethorphan Hydrobromide 15 MG Oral Tablet | SY | 5 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-446-01 | EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 5 | |
| 50580-446-01 | EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 5 |
Products#
Every source-derived product name is available through these pages.
- EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY
- Acetaminophen and Dextromethorphan Hydrobromide
- MICROCRYSTALLINE CELLULOSE
- MAGNESIUM STEARATE
- POWDERED CELLULOSE
- PROPYLENE GLYCOL
- SODIUM STARCH GLYCOLATE TYPE A
- TITANIUM DIOXIDE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- CARNAUBA WAX
- HYPROMELLOSE, UNSPECIFIED
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-446 | 50580-446-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POWDERED CELLULOSE | SMD1X3XO9M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 SEVERE COUGH PLUS SORE THROAT DAY | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 1a17b24a-8022-4e2f-e063-6294a90af276 | 2025-07-17 | Warnings | 50580-446-01 50580-446 50580044601 3a1abd26-c0a9-8a65-e063-6294a90ab66e 1a17b24a-8022-4e2f-e063-6294a90af276 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.