SALINE REFILLS- sodium bicarbonate, sodium chloride powder, for solution

Saline Refills by

Drug Labeling and Warnings

Saline Refills by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 414, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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.

ACTIVE INGREDIENT

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

INACTIVE INGREDIENT

 Inactive Ingredients

None

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALINE REFILLS  
sodium bicarbonate, sodium chloride powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-753
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	2300 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	700 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-753-78	100 in 1 CARTON
1		1 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2013

Labeler - Cardinal Health 414, LLC (097537435)