Indications and uses
■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ runny nose and sneezing ■ temporarily reduces fever
TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS NIGHT
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2026-07-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-07-29 05:10:11
Label at a glance#
ProductTYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, 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 capsules every 6 hours while symptoms last ■ do not take more than 8 capsules in 24 hours children 4 to under 12 years ask a doctor children under 4 years do not use
Storage and handling
■ store between 20-25°C (68-77°F) ■ avoid high humidity and excessive heat above 40°C (104°F) ■ protect from light ■ 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 capsule) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Doxylamine Succinate 6.25 mg | Antihistamine |
Uses
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ runny nose and sneezing
■ 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 containsacetaminophen, 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
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ 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)
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
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 | ■ take 2 capsules every 6 hours while symptoms last ■ do not take more than 8 capsules in 24 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
Other information
■ store between 20-25°C (68-77°F)
■ avoid high humidity and excessive heat above 40°C (104°F)
■ protect from light
■ do not use if blister unit is torn or broken
Inactive ingredients
D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
Questions or comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
NDC 50580-131-24
TYLENOL
®
FOR ADULTS
COLD + FLU
MULTI-SYMPTOM
Liquid Gels
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine
NIGHT
• HEAD + BODY ACHES
• FEVER
• SORE THROAT
• COUGH
• SNEEZING
• RUNNY NOSE
*LIQUID FILLED CAPSULES
Actual Size
24 LIQUID GELS*
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0300450692245 | GTIN-13: 0300450692245 EAN-13: 0300450692245 GTIN-12: 300450692245 UPC-A: 300450692245 GTIN storage (14 digits): 00300450692245 | Tylenol-1.jpg |
| QR code link | QR Code |  2d.kenvue.com/01/00300450692245 | Tylenol-1.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT
- Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- ACETAMINOPHEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- FD&C BLUE NO. 1
- D&C YELLOW NO. 10
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- GELATIN
- MINERAL OIL
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-131 | 50580-131-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| GELATIN | 2G86QN327L | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POVIDONE | FZ989GH94E | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2024-12-12 | full-release | 2026-06-01 00:42:42 |
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 |
|---|---|---|---|---|---|---|
| TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 1c5386c1-e45d-9dcb-e063-6294a90aff07 | 2026-07-22 | Warnings | 50580-131-24 50580-131 50580013124 572ebe9a-09d7-46c2-e063-6394a90a26b5 1c5386c1-e45d-9dcb-e063-6294a90aff07 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.