FDA.reportPublic FDA data

Tylenol Cold Plus Flu Severe

Manufacturer
Select Corporation
Effective date
2022-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:12

Label at a glance#

ProductTylenol Cold Plus Flu Severe
Active ingredientacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Label structure10 sections

Indications and uses

for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 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 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

Storage and handling

each caplet contains: sodium 3 mg store between 20-25°C (68-77°F) do not use if pouch is torn or damaged

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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, chronic bronchitis 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

  • 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 4 hours
  • swallow whole; do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours
children under 12 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA

Product Repackaged and Distributed
with permission of manufacturer by:
Select Corporation, Carrollton, TX 75007

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Single-Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL®
FOR ADULTS

COLD + FLU SEVERE

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever-Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant

2 Caplets
Single-Pack

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Single-Pack
PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Single-Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN1
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-944-042024-01-30C16284748780-11030e365-0e27-111a-e063-dadaa90a10e2Tylenol ® Cold Plus Flu Severe
52904-944-052024-01-30C16284748780-11030e365-0e27-111a-e063-dadaa90a10e2Tylenol ® Cold Plus Flu Severe
52904-944-252024-01-30C16284748780-11030e365-0e27-111a-e063-dadaa90a10e2Tylenol ® Cold Plus Flu Severe
52904-944-502024-01-30C16284748780-11030e365-0e27-111a-e063-dadaa90a10e2Tylenol ® Cold Plus Flu Severe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-944-04Tylenol Cold Plus Flu Severe2 in 1 POUCHTABLET, FILM COATED21
52904-944-04Tylenol Cold Plus Flu Severe1 in 1 BLISTER PACKTABLET, FILM COATED11
52904-944-05Tylenol Cold Plus Flu Severe2 in 1 BLISTER PACKTABLET, FILM COATED21
52904-944-05Tylenol Cold Plus Flu Severe2 in 1 POUCHTABLET, FILM COATED21
52904-944-25Tylenol Cold Plus Flu Severe2 in 1 POUCHTABLET, FILM COATED21
52904-944-25Tylenol Cold Plus Flu Severe25 in 1 CARTONTABLET, FILM COATED251
52904-944-50Tylenol Cold Plus Flu Severe2 in 1 POUCHTABLET, FILM COATED21
52904-944-50Tylenol Cold Plus Flu Severe50 in 1 CARTONTABLET, FILM COATED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-944TYLENOL COLD PLUS FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [SELECT CORPORATION]1Legacy NDC, 8 package rows20220414_f056015b-efb7-43d1-b39d-26d679ad8d2c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-402-25EA - Each50580-4020cc3391e-bdb0-4261-8768-843eeb5a7dbd12012-07-24
50580-402-26EA - Each50580-40230dba1ec-de87-4165-ada8-eec0bd9a7ef112013-03-03

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52904-94452904-944-04, 52904-944-05, 52904-944-25, 52904-944-50
50580-402

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
acetaminophen362O9ITL9DACTIB
dextromethorphan hydrobromide9D2RTI9KYHACTIB
guaifenesin495W7451VQACTIB
phenylephrine hydrochloride04JA59TNSJACTIB
carnauba waxR12CBM0EIZIACT
croscarmellose sodiumM28OL1HH48IACT
D&C yellow no. 10 aluminum lakeCQ3XH3DET6IACT
hydroxypropyl cellulose, unspecified9XZ8H6N6OHIACT
hypromellose, unspecified3NXW29V3WOIACT
magnesium stearate70097M6I30IACT
microcrystalline celluloseOP1R32D61UIACT
polyethylene glycol, unspecified3WJQ0SDW1AIACT
sucralose96K6UQ3ZD4IACT
titanium dioxide15FIX9V2JPIACT

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
e27a61d0-3ab4-4259-a829-7416997876b4f056015b-efb7-43d1-b39d-26d679ad8d2c2022-03-30WarningsExact identifier
spl id: e27a61d0-3ab4-4259-a829-7416997876b4
spl set id: f056015b-efb7-43d1-b39d-26d679ad8d2c

Reported adverse events (FAERS/openFDA)#

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