FDA.reportPublic FDA data

Extra Strength TYLENOL Severe Cough Plus Sore Throat Day

Manufacturer
Kenvue Brands LLC
Effective date
2025-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:21

Label at a glance#

ProductExtra Strength TYLENOL Severe Cough Plus Sore Throat Day
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 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) shake well before using mL = milliliter use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 30 mL in the dosing cup provided every 6 hours while symptoms last do not take more than 90 mL in 24 hours, unless directed by a doctor do not use for more than 10 days unless dire...

Storage and handling

each 30 mL contains: sodium 19 mg store between 20-25°C (68-77°F) do not use if neck band imprinted with “INSTANT COOLING SENSATION” or foil inner seal imprinted with “TYLENOL” is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients(in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 1,000 mg

Dextromethorphan HBr 30 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough 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

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

Allergy alert

SPL UNCLASSIFIED SECTION

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
  • 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

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose

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.

If pregnant or breast-feeding,

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

  • do not take more than directed(see overdose warning)
  • shake well before using
  • mL = milliliter
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults and children
12 years and over
  • take 30 mL in the dosing cup provided every 6 hours while symptoms last
  • do not take more than 90 mL 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

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 19 mg
  • store between 20-25°C (68-77°F)
  • do not use if neck band imprinted with “INSTANT COOLING SENSATION” or foil inner seal imprinted with

“TYLENOL” is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, FD&C red no 40, flavors, glycerin,microcrystalline cellulose and carboxymethylcellulose sodium,poloxamer, polyethylene glycol,propylene glycol, purified water,sodium benzoate, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665 (toll-free) or

215-273-8755 (collect)

PRINICIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

NDC 50580-140-08

EXTRA STRENGHT TYLENOL ®

FOR ADULTS

SEVERE COUGH + SORE THROAT

Acetaminophen,

Dextromethorphan HBr, Pain Reliever-Fever Reducer, Cough Suppressant

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

DAY

COOLING CHERRY

8 fl oz (240 mL)

tylenol.jpgtylenol.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1359455acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN1
1359455acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD1
1359455acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSY1
1359455acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY1
1359455APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-140-08Extra Strength TYLENOL Severe Cough Plus Sore Throat Day240 mL in 1 BOTTLELIQUID2401

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-14050580-140-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
FD&C RED NO. 40WZB9127XOAIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
ACETAMINOPHEN362O9ITL9DACTIB
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT

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 Severe Cough Plus Sore Throat DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC2e9540e4-bd1d-9370-e063-6294a90affcb2025-03-07WarningsExact identifier
ndc (package): 50580-140-08
ndc (product): 50580-140
ndc11 (package): 50580014008
spl id: 2e9540e4-bd1e-9370-e063-6294a90affcb
spl set id: 2e9540e4-bd1d-9370-e063-6294a90affcb

Reported adverse events (FAERS/openFDA)#

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