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  5. Label Information: Nasal Decongestant Pe

FDA Label for Nasal Decongestant Pe

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - WHEN USING
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Nasal Decongestant Pe Product Label

The following document was submitted to the FDA by the labeler of this product Hhh Pharma Usa 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 Caplet)



Phenylephrine HCl 10mg


Purpose



Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

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.

Otc - When Using



When using this product do not exceed recommended dose.


Stop Use And Ask A Doctor If



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away.


Directions



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

Other Information



  • each tablet contains: phosphorus 10 mg
  • store at controlled room temperature between 20°-25°C (68°-77°F)
  • protect from excessive moisture
  • read all product information before using

Inactive Ingredients



Crosscarmellose Soidum, Colloidal Silicon Dioxide, Dicalcium Phosphate, FD&C Red 40, Magnesium Stearate, Microcrystalline Cellulose


Questions Or Comments?



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