Active Ingredient (In Each Caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Savings Distributors Llc for the product Tylenol Sinus Severe (NDC 73097-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Expectorant
Nasal decongestant
■ 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
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.
■ 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 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)
taking the blood thinning drug warfarin
do not exceed recommended dose
■ 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.
ask a health professional before use.
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.
■ do not take more than directed (see overdose warning)
adults and children 12 years ■ take 2 caplets every 4 hours
and over ■ 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
■ each caplet contains: sodium 3 mg
■ store between 20-25°C (68-77°F)
■ do not use if pouch is tron or damaged
carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
* Please review the disclaimer below.