Indications and uses
■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ■ temporarily reduces fever
■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ■ temporarily reduces fever
■ do not take more than directed (see overdose warning) Adults and children 12 years and over: ■ take 2 caplets every 4 hours while symptoms last ■ do not take more than 10 caplets in 24 hours Children under 12 years: ■ ask a doctor
■ each caplet contains: sodium 3 mg ■ store between 20-25°C (68-77°F) ■ do not use if blister unit is torn or broken
Drug Facts
Acetaminophen 325 mg
Guaifenesin 200 mg
Pain reliever/fever reducer
Expectorant
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat
■ helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more productive
■ 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
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 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, chronic bronchitis 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
■ 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.
■ do not take more than directed (see overdose warning)
| Adults and children
12 years and over: | ■ take 2 caplets every 4 hours while symptoms last
■ do not take more than 10 caplets in 24 hours |
| Children under 12 years: | ■ ask a doctor |
■
each caplet contains: sodium 3 mg
■ store between 20-25°C (68-77°F)
■
do not use if blister unit is torn or broken
croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose,
pregelatinized starch, titanium dioxide, triacetin
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect).
NEW
NDC 50580-584-24
TYLENOL ®
FOR ADULTS
COLD + FLU +
CHEST CONGESTION
Acetaminophen, Guaifenesin
Pain Reliever-Fever Reducer, Expectorant
• HEADACHE + BODY ACHES
• FEVER
• SORE THROAT
• MUCUS + CHEST CONGESTION
COOL COATED
Actual Size
24 CAPLETS
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0300450153241 | GTIN-13: 0300450153241 EAN-13: 0300450153241 GTIN-12: 300450153241 UPC-A: 300450153241 GTIN storage (14 digits): 00300450153241 | tylenol -1.jpg |
| QR code link | QR Code | tylenol -1.jpg | ||
| Data code | Code 128 | 30062380 | tylenol -1.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-584-10 | Tylenol Cold Plus Flu Plus Chest Congestion | 50 in 1 CARTON | TABLET, FILM COATED | 50 | 1 | |
| 50580-584-10 | Tylenol Cold Plus Flu Plus Chest Congestion | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 1 | |
| 50580-584-24 | Tylenol Cold Plus Flu Plus Chest Congestion | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 1 | |
| 50580-584-24 | Tylenol Cold Plus Flu Plus Chest Congestion | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 1 | |
| 50580-584-50 | Tylenol Cold Plus Flu Plus Chest Congestion | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 1 | |
| 50580-584-50 | Tylenol Cold Plus Flu Plus Chest Congestion | 2500 in 1 CASE | TABLET, FILM COATED | 2500 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50580-584 | 50580-584-50, 50580-584-10, 50580-584-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| HYDROXYPROPYL CELLULOSE, UNSPECIFIED | 9XZ8H6N6OH | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Tylenol Cold Plus Flu Plus Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Kenvue Brands LLC | 4e60e1ad-4ad4-c329-e063-6294a90ab318 | 2026-04-08 | Warnings | 50580-584-24 50580-584-50 50580-584-10 50580-584 50580058450 50580058424 50580058410 4e60e1ad-4ad5-c329-e063-6294a90ab318 4e60e1ad-4ad4-c329-e063-6294a90ab318 |
Adverse event summaries are temporarily unavailable. Other product information remains available.