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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 TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. OTHER
    13. PRINCIPAL DISPLAY PANEL-36 COUNT
    14. PRINCIPAL DISPLAY PANEL-100 COUNT

Nasal Decongestant Pe Product Label

The following document was submitted to the FDA by the labeler of this product Bi-mart. 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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

Warnings



Do not use ifyou 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.

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 - 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 between 20°-25°C (68°-77°F)
  • protect from excessive moisture
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients



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


Questions?



call toll free 1-844-912-4012


Other



Distributed by:

BI-MART

Eugene, OR 97402


Principal Display Panel-36 Count



NDC 37835-651-36

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

36 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.

label - label 36

label - label 36


Principal Display Panel-100 Count



NDC 37835-651-01

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.

label - label 100

label - label 100


* Please review the disclaimer below.