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  5. Label Information: Leader Sinus Wash Saline Refill Packets

FDA Label for Leader Sinus Wash Saline Refill Packets

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. OTHER SAFETY INFORMATION
    8. OTC - QUESTIONS
    9. SPL PATIENT PACKAGE INSERT
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Sinus Wash Saline Refill Packets Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. 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 Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg


Otc - Purpose



Purpose

Nasal Wash


Indications & Usage



Uses

Temporarily relieves symptoms associated with sinusitis, cold, flu  or allergies:

   •Sneezing               •Runny nose

   •Nasal stuffiness      •Post nasal drip

•Removes inhaled irritants (dust, pollen)

•Promotes nasal and sinus drainage

•Helps reduce swelling of nasal membranes

•Moisturizes dry nasal passages


Otc - Keep Out Of Reach Of Children



Keep out of reach of children


Warnings



Warnings

• Stop use and ask a  doctor if washing is uncomfortable or symptoms are not relieved.

• Do not use unfiltered tap water, see instructions inside box for for proper water sources.

• Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.


Dosage & Administration



Directions

Adults and children

4 years and over:

 Use 1-2 packets per 8 fl oz(240 mL)

up to every 2 hours as needed

 Children under 4 years: Consult a physician
 See enclosed instruction sheetfor complete directions and proper use


Other Safety Information



Other information

  • Inspect saline packets for integrity
  • Do not use saline packets if open or torn
  • Protect saline packets from excessive heat and moisture
  • See saline packets or box for lot # and expiration date

Otc - Questions



Questions?

1-888-547-5492


Spl Patient Package Insert



image description - Instruc1 100

image description - Instruc1 100


Inactive Ingredient



Inactive Ingredients

None


Package Label.Principal Display Panel



image description - Leader100 0517

image description - Leader100 0517


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