SALINE REFILLS  - sodium bicarbonate, sodium chloride powder, for solution 
Cardinal Health 414, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Purpose

Nasal Wash

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

Keep out of reach from children

Warnings

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


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

 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

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.

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

 Inactive Ingredients

None

copy of label

SALINE REFILLS  
sodium bicarbonate, sodium chloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-753
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE2300 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE700 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-753-78100 in 1 CARTON
11 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/2013
Labeler - Cardinal Health 414, LLC (097537435)

Revised: 5/2013
Document Id: a29d6d05-a22d-4eca-9e2c-e791d89e9655
Set id: c9d8ef33-46ed-4c60-842c-7d23f12bfcb9
Version: 4
Effective Time: 20130522
 
Cardinal Health 414, LLC