FDA Label for Saline Refills
View Indications, Usage & Precautions
Saline Refills Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 414, Llc. 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 - 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)
Promotes nasal and sinus drainage
Helps reduce swelling of nasal membranes
Otc - Keep Out Of Reach Of Children
Keep out of reach from children
Warnings
Warnings
Stop use and ask a doctor if washing is uncomfortable or symptoms are not relieved
Dosage & Administration
Directions
Adults and children 4 years and over: use 1-2 packets every 2 hours as needed
Children under 4 years: consult a doctor
Consult Instructions for Use for proper use
Otc - When Using
When using this product:
-Use by only one person
-Wash with soap and water after each use
-Top rack of dishwasher safe
-Do not heat in microwave
Instructions For Use
Instructions for Use
Directions: Read through entire section before using for the first time.
1. Empty the contents of one Saline Sinus Wash packet into the Classic Neti pot. First-time users should start with 1/2 of the dry ingredients.
As you become more accustomed to the system, work up to suing 1 full packet. Additional packets may be purchased from your nearest pharmacy.
2. Fill the pot halfway or to the middle of the indentation with proper water. This makes 1/2 cup (4 oz) solution.
3. Stir thoroughly until dry ingredients have completely dissolved.
4. Proper head position allows the solution to run through the nose by gravity.
-Lean over the sink so you are looking directly into the basin. Holding the pot in your right hand, gently insert the spout into your right
nostril so that it forms a comfortable seal.
-Rotate your head so that the right nostril is directly above the left. The forehead should remain higher than the chin. Raise the handle of the pot so that the
solution enters the right nostril. In a few moments, the solution will begin to drain out of the left nostril into the sink. Do no inhale or "snort" solution into the nose -
breathe through your mouth.
5. When the pot is empty, exhale through both nostrils to clear them of excess mucous and solution. Gently blow your nose into a tissue.
6. Repeat the procedure on the other side..
7. Thoroughly rinse the pot with water that has been distilled, sterilized, filtered or previously boiled and leave the pot to air dry completely.
The Classic Neti Pot is top-rack dishwasher safe.
Otc - Active Ingredient
Active Ingredients
(in each packet)
Sodium Bicarbonate USP 700 mg
Sodium Chloride USP 2300 mg
Inactive Ingredient
Inactive Ingredients
None
Package Label.Principal Display Panel
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