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  5. Label Information: Tylenol Sinus Severe

FDA Label for Tylenol Sinus Severe

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE LABELING

Tylenol Sinus Severe Product Label

The following document was submitted to the FDA by the labeler of this product Jc World Bell Wholesale Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Caplet)



Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Purpose



Pain reliever/fever reducer

Expectorant

Nasal decongestant


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.

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)

Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin


When Using This Product



do not exceed recommended dose


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.


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 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.


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


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


Questions Or Comments?



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


Package Labeling



Label2 - Label2

Label2 - Label2


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