FDA.reportPublic FDA data

Extra Strength TYLENOL Cold Plus Flu Multi-Action

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:35:40

Label at a glance#

ProductExtra Strength TYLENOL Cold Plus Flu Multi-Action Day
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage 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#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Pseudoephedrine HCl 30 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • sinus congestion and pressure
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion 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)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-344-01

Extra Strength

TYLENOL ®

FOR ADULTS

COLD + FLU MULTI-ACTION

Acetaminophen,

Dextromethorphan HBr, Pseudoephedrine HCl

Pain Reliever-Fever Reducer, Cough Suppressant, Nasal Decongestant

DAY

NON-DROWSY

  • HEAD + BODY ACHES
  • FEVER + SORE THROAT
  • COUGH
  • NASAL CONGESTION

Actual Size

24 CAPLETS

tylenol-01tylenol-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1250743acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral TabletPSN8
1250743acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD8
1250743APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral TabletSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-344-01Extra Strength TYLENOL Cold Plus Flu Multi-ActionDay12 in 1 BLISTER PACKTABLET, FILM COATED128
50580-344-01Extra Strength TYLENOL Cold Plus Flu Multi-ActionDay2 in 1 CARTONTABLET, FILM COATED28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-344EXTRA STRENGTH TYLENOL COLD PLUS FLU MULTI-ACTION DAY (ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]8Current NDC, Legacy NDC, 2 package rows20241109_7d3266dc-879a-4d28-b8ea-74d238c3020a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-344-01EA - Each50580-344bb42db4e-7a0c-40fb-ac80-ce52e5c2bac112021-08-05

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-34450580-344-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POWDERED CELLULOSESMD1X3XO9MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CARNAUBA WAXR12CBM0EIZIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ACETAMINOPHEN362O9ITL9DACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength TYLENOL Cold Plus Flu Multi-Action DayACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC7d3266dc-879a-4d28-b8ea-74d238c3020a2024-11-07WarningsExact identifier
ndc (package): 50580-344-01
ndc (product): 50580-344
ndc11 (package): 50580034401
spl id: 21702ebc-459b-7f5a-e063-6294a90ad432
spl set id: 7d3266dc-879a-4d28-b8ea-74d238c3020a

Reported adverse events (FAERS/openFDA)#

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