Tylenol ®

Tylenol ®
SPL v14
SPL
SPL Set ID e608d214-cc46-4a24-ac85-1040e36e7403
Route
ORAL
Published
Effective Date 2020-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Carnauba Wax D&c Yellow No. 10 Aluminum Lake Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Aluminum Oxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Potassium Sorbate Powdered Cellulose Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Starch Glycolate Type A Sucralose Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TYLENOL;1080 Shape: oval Color: green Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-07-15 Until 2021-10-31
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • minor aches and pains
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Phenylephrine HCl 5 mg Nasal decongestant
Directions
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
Do Not Use
  • 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.
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
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.

Other Information
  • store between 20-25°C (68-77°F)
  • do not use if blister unit is torn or broken
Inactive Ingredients

anhydrous citric acid, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide

Questions Or Comments?

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

Principal Display Panel

NDC 50580-598-02

TYLENOL ®

FOR ADULTS

SINUS

+ HEADACHE

Acetaminophen,

Phenylephrine HCl

Pain Reliever–Fever Reducer,

Nasal Decongestant

DAY

NON-DROWSY

  • SINUS HEADACHE
  • SINUS PRESSURE
  • NASAL CONGESTION

Actual Size

24 CAPLETS

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion 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

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • minor aches and pains
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Phenylephrine HCl 5 mg Nasal decongestant
Directions
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
Do Not Use (Do not use)
  • 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.
Liver Warning (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
Overdose Warning (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.

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • do not use if blister unit is torn or broken
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-598-02

TYLENOL ®

FOR ADULTS

SINUS

+ HEADACHE

Acetaminophen,

Phenylephrine HCl

Pain Reliever–Fever Reducer,

Nasal Decongestant

DAY

NON-DROWSY

  • SINUS HEADACHE
  • SINUS PRESSURE
  • NASAL CONGESTION

Actual Size

24 CAPLETS

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion 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

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:21.638011 · Updated: 2026-03-14T23:05:02.267888