FDA Label for Sinus Wash Saline Refills Premier Value
View Indications, Usage & Precautions
Sinus Wash Saline Refills Premier Value Product Label
The following document was submitted to the FDA by the labeler of this product Premier Value. 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
-Nasal stuffiness
-Runny nose
-Post nasal drip
Removes inhaled irritants (dust, pollen)
Removes 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 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 sheet for complete directions and proper use.
Inactive Ingredient
Inactive ingredients
None
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
-See instruction sheet for use
Otc - Questions
Questions?
1-888-547-5492
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