FDA Label for Nasal And Sinus Decongestant

View Indications, Usage & Precautions

Nasal And Sinus Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Jhk Inc Dba American Safety & First Aid. 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.

Other



Drug Facts


Active Ingredient (In Each Tablets)



Phenylephrine HCl 5 mg


Purpose



nasal decongestant


Use



temporarily relieves nasal congestion due to:

  • common cold
  • hay fever or other upper respiratory allergies

Otc - Do Not Use



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 an MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.


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

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 are accompanied by fever
  • new symptoms occur

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 right away.


Directions



  • Adults and children 12 years of age and older take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor
  • Children under 12 years of age: ask a doctor

Other Information



  • do not use if packet is opened or torn
  • store at room temperature, 59° - 86°F (15° - 30°C)
  • avoid excessive heat and humidity

Inactive Ingredients



croscarmellose sodium, D&C Red #27, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid


Questions?



1-866-651-3660 Monday-Friday

8:00am-5:00pm EST


Principal Display Panel - 100 Tablet Box



Product #1262

Nasal & Sinus
Decongestant II

Nasal Decongestant

Active ingredient:
Phenylephrine

  • Helps reduce nasal and sinus congestion and
    pressure, and helps restore free breathing
    through the nose
  • These quality comfort tablets are formulated and packaged for use in the
    workplace and meet ANSI Z308.1-2015 standards. They are sealed in
    tamper-evident packets for safety and convenience.

    100 Tablets • 2 Tablets Per Packet


Principal Display Panel - 250 Tablet Box



Product #1264

Nasal & Sinus
Decongestant II

Nasal Decongestant

Active ingredient:
Phenylephrine

  • Helps reduce nasal and sinus congestion and
    pressure, and helps restore free breathing
    through the nose
  • These quality comfort tablets are formulated and packaged for use in the
    workplace and meet ANSI Z308.1-2015 standards. They are sealed in
    tamper-evident packets for safety and convenience.

    250 Tablets • 2 Tablets Per Packet


* Please review the disclaimer below.