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  5. Label Information: First Aid Direct Nasal And Sinus Decongestant

FDA Label for First Aid Direct Nasal And Sinus Decongestant

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. OTHER SAFETY INFORMATION
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PRINCIPAL DISPLAY PANEL - 25 CT BOX

First Aid Direct Nasal And Sinus Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Cintas Corporation. 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.

Otc - Active Ingredient



Active ingredient (in each tablet)

Phenylephrine HCl 10 mg


Otc - Purpose



Purpose

Nasal decongestant


Indications & Usage



Uses

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

Warnings



Warnings


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


Otc - Ask Doctor



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


Otc - Stop Use



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. 


Dosage & Administration



Directions

Adults and children 12 years and over:

  • 1 tablet every 4 hours
  • do not take more than 6 tablets in 24 hours

    • Children under 12 years: ask a doctor


Other Safety Information



Other information

  • store at room temperature 20°-25°C (68°-77°F)
  • do not use if packet is opened or torn

Inactive Ingredient



Inactive ingredients

croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide


Otc - Questions



Questions or comments?

Call 1-800-327-2704 M-F 8AM-5PM


Principal Display Panel - 25 Ct Box



NASAL & SINUS DECONGESTANT 

  • Compare to active ingredients in SUDAFED PE® Sinus Congestion*
  • Helps to temporarily relieve: sinus congestion and pressure, nasal congestion due to the common cold, hay fever or other upper respiratory allergies 

    • 25 Tablets • 1 Tablet per Packet

    NASAL & SINUS DECONGESTANT

    Active Ingredient:

    Phenylephrine HCl 10 mg

    • Compare to active ingredients in SUDAFED PE® Sinus Congestion*
    • Aspirin-free formula

      • 25 Tablet • 1 Tablet per Packet

      Product #112350

      Label_01 - Label 01

      Label_01 - Label 01


* Please review the disclaimer below.