FDA.reportPublic FDA data

Tylenol

Manufacturer
Select Consumer Group LLC | Select Consumer Group
Effective date
2026-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:36:33

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 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

  • 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 aretaking 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

Tylenol Sinus -2Tylenol Sinus -2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708229637GTIN-13: 0655708229637
EAN-13: 0655708229637
GTIN-12: 655708229637
UPC-A: 655708229637
GTIN storage (14 digits): 00655708229637		2622963015 - Tylenol Sinus Severe - 1955-2.jpg

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

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
85237-195585237-1955-0, 85237-1955-1, 85237-1955-2, 85237-1955-3, 85237-1955-4, 85237-1955-6, 85237-1955-7
50580-507

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
ndc (package): 85237-1955-7
ndc (package): 85237-1955-2
ndc (package): 85237-1955-6
ndc (package): 85237-1955-1
ndc (package): 85237-1955-0
ndc (package): 85237-1955-3
ndc (package): 85237-1955-4
ndc (product): 85237-1955
ndc11 (package): 85237195501
ndc11 (package): 85237195504
ndc11 (package): 85237195507
ndc11 (package): 85237195506
ndc11 (package): 85237195500
ndc11 (package): 85237195502
ndc11 (package): 85237195503
spl id: 52c5c1df-46bc-f82a-e063-6294a90af6f0
spl set id: 52c5fda0-c358-72e8-e063-6394a90a3f68
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC7a60184f-91a9-4b85-b243-871deca634502024-11-01WarningsExact identifier
ndc (product): 50580-507

Reported adverse events (FAERS/openFDA)#

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