TYLENOL SINUS CONGESTION AND PAIN SEVERE- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, film coated
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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TYLENOL®
SINUS
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
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
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)
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.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Other information
- each caplet contains: sodium 3 mg
- store between 20-25°C (68-77°F)
- do not use if carton is opened or if blister unit is broken
Inactive ingredients
carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin
PRINCIPAL DISPLAY PANEL
NDC 50580-324-25
See New Warnings Information & Directions
TYLENOL®
SINUS
CONGESTION & PAIN
SEVERE
For Adults
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever/Fever Reducer, Nasal Decongestant, Expectorant
DAYTIME
Non-Drowsy
Sinus Headache
Nasal Congestion, Sinus Pressure
Clears Mucus, Chest Congestion
24 CAPLETS
| TYLENOL SINUS CONGESTION AND PAIN SEVERE
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, film coated |
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| Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358) |