FDA Label for Nasal Decongestant Pe

View Indications, Usage & Precautions

Nasal Decongestant Pe Product Label

The following document was submitted to the FDA by the labeler of this product Nuvicare Llc. 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 Tablet)



Phenylephrine HCl 10mg


Purpose



Nasal decongestant


Uses:



■ temporarily relieves sinus congestion and pressure

■ temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies


Warnings:



Do not use 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.


Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stope Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever. 

Directions:



  • take 1 tablet every 4 hours
  • adults and children 12 years and over: do not take more than 6 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information:



  • store between 20-25 °C (68-77 °F)
  • do not use if seal under cap is broken or missing

Inactive Ingredients:



Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Polyvinyl Alcohol, Polyethylene Glycol, FD& Red #40/Allura Red AC Aluminum Lake, Talc, Titanium Dioxide


Questions Or Comments ?



Call 1 (718) 337-8733 or visit: [email protected]


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