FDA.reportPublic FDA data

Tylenol

Manufacturer
Kenvue Brands LLC
Effective date
2026-09-25
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
daily-update
Hydrated at
2026-10-10 01:03:37

Label at a glance#

ProductTylenol Sinus Severe
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: sinus congestion and pressure headache nasal congestion minor aches and pains 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
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • sinus congestion and pressure
    • headache
    • nasal congestion
    • minor aches and pains
  • 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.

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, 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 50580-507-04

TYLENOL ®

FOR ADULTS

SINUS SEVERE

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

  • SINUS HEADACHE
  • SINUS PRESSURE
  • NASAL CONGESTION
  • MUCUS + CHEST CONGESTION

DAY NON-DROWSY

Actual Size

50 Pouches of 2 Caplets each

Tylenol-1Tylenol-1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300450262530GTIN-13: 0300450262530
EAN-13: 0300450262530
GTIN-12: 300450262530
UPC-A: 300450262530
GTIN storage (14 digits): 00300450262530		Tylenol-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-507-01EA - Each50580-507ee10d929-4cd2-4906-8663-c84fe7e61be412016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
GuaifenesinACTIVE INGREDIENT495W7451VQ1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
GuaifenesinACTIVE MOIETY495W7451VQ1
PhenylephrineACTIVE MOIETY1WS297W6MV1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZ1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH481
hydroxypropyl cellulose (type e)INACTIVE INGREDIENT66O7AQV0RT1
hypromellosesINACTIVE INGREDIENT3NXW29V3WO1
magnesium stearateINACTIVE INGREDIENT70097M6I301
sucraloseINACTIVE INGREDIENT96K6UQ3ZD41
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
triacetinINACTIVE INGREDIENTXHX3C3X6731

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
50580-50750580-507-01, 50580-507-03, 50580-507-04, 50580-507-02

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
162024-11-01full-release2026-06-01 00:33:25

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 3 · 140 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
hydroxypropyl cellulose (type e)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, DELAYED RELEASE / ORAL83 mgExact identifier — unii+route
15 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
90 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
hydroxypropyl cellulose (type e)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, DELAYED RELEASE / ORAL83 mgExact identifier — unii+route
15 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
90 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
90 equally ranked IID candidates
hydroxypropyl cellulose (type e)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, EXTENDED RELEASE / ORAL23 mgExact identifier — unii+route
15 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
90 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
90 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
90 equally ranked IID candidates
hydroxypropyl cellulose (type e)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, EXTENDED RELEASE / ORAL23 mgExact identifier — unii+route
15 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
90 equally ranked IID candidates
hydroxypropyl cellulose (type e)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, DELAYED RELEASE / ORAL83 mgExact identifier — unii+route
15 equally ranked IID candidates
hydroxypropyl cellulose (type e)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, EXTENDED RELEASE / ORAL23 mgExact identifier — unii+route
15 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
90 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
90 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
90 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
90 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
90 equally ranked IID candidates
hydroxypropyl cellulose (type e)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, EXTENDED RELEASE / ORAL23 mgExact identifier — unii+route
15 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
90 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
90 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
90 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
2172ef51-bd7d-a040-e063-6394a90aeac37a60184f-91a9-4b85-b243-871deca634502024-11-01WarningsExact identifier
spl set id: 7a60184f-91a9-4b85-b243-871deca63450

Reported adverse events (FAERS/openFDA)#

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