Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day Night

Manufacturer
Kenvue Brands LLC
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-03 03:04:26

Label at a glance#

ProductExtra Strength Tylenol Cold Plus Flu Multi-Symptom Day Night
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE
Label structure17 sections

Indications and uses

■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ temporarily reduces fever

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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

EXTRA STRENGTH TYLENOL COLD Plus FLU MULTI-SYMPTOM DAY

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains

■ headache

■ sore throat

■ cough

■ temporarily reduces fever

Warnings

WARNINGS SECTION

Warnings

Liver warning

SPL UNCLASSIFIED SECTION

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: 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.

Sore throat warning

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

■ 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

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

■ store between 20-25°C (68-77°F)
■ do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665(toll-free) or 215-273-8755(collect)

Drug Facts

SPL UNCLASSIFIED SECTION

EXTRA STRENGTH TYLENOL COLD + FLU MULTI-SYMPTOM NIGHT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

OTC - PURPOSE SECTION

Active ingredient (in each capsule)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan HBr 15 mgCough suppressant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains

■ headache

■ sore throat

■ cough

■ sneezing and runny nose

■ temporarily reduces fever

WARNINGS SECTION

Warnings

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

■ 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)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

■ 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

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

■ store between 20 - 25°C (68 - 77°F)
■ do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

tylenol-1.jpgtylenol-1.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300450159342GTIN-13: 0300450159342
EAN-13: 0300450159342
GTIN-12: 300450159342
UPC-A: 300450159342
GTIN storage (14 digits): 00300450159342
tylenol-1.jpg
QR code linkQR Code2d.kenvue.com/01/00300450159342tylenol-1.jpg
Data codeCode 12830062287tylenol-1.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-58550580-585-01
50580-586
50580-684

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
ndc (package): 50580-585-01
ndc (product): 50580-585
ndc11 (package): 50580058501
spl id: 594f5167-2628-8160-e063-6294a90aa943
spl set id: 594f515c-b369-816d-e063-6294a90a59a1
Extra Strength TYLENOL Cold plus Flu Multi Symptom DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5487b2e1-b0e5-0236-e063-6394a90a3a8b2026-06-18WarningsExact identifier
ndc (product): 50580-586

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.