FDA.reportPublic FDA data

TYLENOL SINUS SEVERE

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:34:15

Label at a glance#

ProductTYLENOL SINUS SEVERE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, GUAIFENESIN
Label structure13 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#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Purpose

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

WARNINGS SECTION

Liver warning

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

Allergy alert

WARNINGS 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)

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 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

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)

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)

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

SPL UNCLASSIFIED SECTION

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

Repackaged and distributed by: Convenience Valet ®, Glendale Heights, IL 60139

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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


2 POUCHES OF 2 CAPLETS EACH

Tylenol Sinus 4ctTylenol Sinus 4ct

PRINCIPAL DISPLAY PANEL 25ct Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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


25 POUCHES OF 2 CAPLETS EACH

Tylenol Sinus 25ctTylenol Sinus 25ct

PRINCIPAL DISPLAY PANEL 30ct Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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


30 POUCHES OF 2 CAPLETS EACH

Tylenol Sinus 30ctTylenol Sinus 30ct

CVP 4 Count Carton

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

HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST
CONGESTION

4

Caplet

2 Pouches of 2 Caplets each

CVP

HEALTH

Tylenol Sinus Severe CVP 4ctTylenol Sinus Severe CVP 4ct

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
29485-655729485-6557-4
29485-805529485-8055-4
29485-805729485-8057-2, 29485-8057-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACETAMINOPHEN362O9ITL9DACTIB
CARNAUBA WAXR12CBM0EIZIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSES3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACETAMINOPHEN362O9ITL9DACTIB
CARNAUBA WAXR12CBM0EIZIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSES3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACETAMINOPHEN362O9ITL9DACTIB
CARNAUBA WAXR12CBM0EIZIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
HYPROMELLOSES3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MAGNESIUM STEARATE70097M6I30IACT

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
4615aa0b-e96b-45af-e063-6394a90a7de8d333b09f-b13e-5b41-e053-2995a90a33122025-12-16WarningsExact identifier
spl id: 4615aa0b-e96b-45af-e063-6394a90a7de8
spl set id: d333b09f-b13e-5b41-e053-2995a90a3312

Reported adverse events (FAERS/openFDA)#

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