Tylenol Sinus Severe

Tylenol Sinus Severe
SPL v1
SPL
SPL Set ID 1560b3a0-fe81-4e33-b581-20b43511dba3
Route
ORAL
Published
Effective Date 2025-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Carnauba Wax Croscarmellose Sodium Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Sucralose Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: TYLENOL;1072 Shape: oval Color: white Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-05-15

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

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
Warnings

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:acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening • blisters • rash

    If a skin reactions occurs, stop use and seek medical help right away.

    Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • 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

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.
Drug Facts

Other Information
  • each caplet contains:sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged
Package Labeling:

Inactive Ingredients

carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin

Questions Or Comments?

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

When Using This Product,

do not exceed recommended dose

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleepless occurs
  • 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,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warning:In case of overdose, get medical helo or contact a Posion 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.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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

taking the blood thinning drug warfarin.


Structured Label Content

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
Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Warnings

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:acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening • blisters • rash

    If a skin reactions occurs, stop use and seek medical help right away.

    Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • 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

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.
Drug Facts

Other Information (Other information)
  • each caplet contains:sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged
Package Labeling:

Inactive Ingredients (Inactive ingredients)

carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

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

When Using This Product, (When using this product,)

do not exceed recommended dose

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleepless occurs
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning:In case of overdose, get medical helo or contact a Posion 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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver desease
  • heart disease
  • high blood pressure 
  • thyroid disease
  • diabetes 
  • trouble urinating due to 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 (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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