FDA.reportPublic FDA data

Tylenol

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 00:36:14

Label at a glance#

ProductTylenol Cold Plus Head Congestion Severe
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion sinus congestion and pressure 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 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 325 mgPain reliever/fever reducer
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of the following cold symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • sinus congestion and pressure
  • 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 blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, 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 50580-566-25
TYLENOL ®
FOR ADULTS

COLD + HEAD
CONGESTION SEVERE

Acetaminophen,
Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer,
Nasal Decongestant, Expectorant

  • HEADACHE + BODY ACHES
  • FEVER + SORE THROAT
  • NASAL CONGESTION
  • MUCUS + CHEST
    CONGESTION

Actual Size

24 CAPLETS

Principal Display Panel
Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN16
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD16
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY16
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY16

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-566-25TylenolCold Plus Head Congestion Severe2 in 1 CARTONTABLET, FILM COATED216
50580-566-25TylenolCold Plus Head Congestion Severe12 in 1 BLISTER PACKTABLET, FILM COATED1216

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-566TYLENOL COLD PLUS HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 2 package rows20241109_ce43e5c2-fe96-4462-882c-d7479318b33d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D2
GuaifenesinACTIVE INGREDIENT495W7451VQ2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ2
AcetaminophenACTIVE MOIETY362O9ITL9D2
GuaifenesinACTIVE MOIETY495W7451VQ2
PhenylephrineACTIVE MOIETY1WS297W6MV2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZ2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH482
hydroxypropyl cellulose (type e)INACTIVE INGREDIENT66O7AQV0RT2
hypromellosesINACTIVE INGREDIENT3NXW29V3WO2
magnesium stearateINACTIVE INGREDIENT70097M6I302
sucraloseINACTIVE INGREDIENT96K6UQ3ZD42
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP2
triacetinINACTIVE INGREDIENTXHX3C3X6732

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
50580-56650580-566-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 52 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
36 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
36 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
36 equally ranked IID candidates
hydroxypropyl cellulose (type e)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTTABLET, FILM COATED / ORAL15 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
36 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
36 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
36 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
36 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
hydroxypropyl cellulose (type e)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTTABLET, FILM COATED / ORAL15 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
36 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
36 equally ranked IID candidates

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
Tylenol Cold Plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCce43e5c2-fe96-4462-882c-d7479318b33d2024-11-07WarningsExact identifier
ndc (package): 50580-566-25
ndc (product): 50580-566
ndc11 (package): 50580056625
spl id: 21aceda5-2c34-23df-e063-6394a90acb09
spl set id: ce43e5c2-fe96-4462-882c-d7479318b33d

Reported adverse events (FAERS/openFDA)#

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