Severe Sinus Congestion And Pain
103de130-ef12-4c58-bbcf-234b3f3b2cbf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Pain reliever/fever reducer Expectorant Nasal decongestant
Medication Information
Purpose
Pain reliever/fever reducer
Expectorant
Nasal decongestant
Description
Drug Facts
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children.
Section 50566-9
Stop use and ask a doctor if
• 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.
Section 50567-7
When using this productdo not exceed recommended dose
Section 50568-5
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin
Section 50569-3
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
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
Section 50570-1
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.
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
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 reaction occurs, stop use and seek medical help right away.
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 |
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)
Inactive Ingredients
croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol , polyvinyl alcohol, povidone, purified water, starch, talc, titanium dioxide
Questions Or Comments?
1-800-373-6981 (toll-free)
Principal Display Panel
Compare to the active ingredients in Tylenol® Sinus Severe
Severe Sinus Congestion & Pain
Acetaminophen,
Guaifenesin, Phenylephrine HCl
Carton
Active Ingredients (in Each Caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Structured Label Content
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
• 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.
Section 50567-7 (50567-7)
When using this productdo not exceed recommended dose
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin
Section 50569-3 (50569-3)
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
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
Section 50570-1 (50570-1)
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.
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
Purpose
Pain reliever/fever reducer
Expectorant
Nasal decongestant
uses (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 reaction occurs, stop use and seek medical help right away.
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 |
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)
Inactive Ingredients (Inactive ingredients)
croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol , polyvinyl alcohol, povidone, purified water, starch, talc, titanium dioxide
Questions Or Comments? (Questions or comments?)
1-800-373-6981 (toll-free)
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Compare to the active ingredients in Tylenol® Sinus Severe
Severe Sinus Congestion & Pain
Acetaminophen,
Guaifenesin, Phenylephrine HCl
Carton
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:08:59.819559 · Updated: 2026-03-14T23:13:32.363247