Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID d7e58c98-102d-4ae5-9af0-c9f38a0c18b6
Route
NASAL
Published
Effective Date 2013-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (2300 mg) Sodium Cation (700 mg)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-04-01

Description

Purpose Nasal Wash


Medication Information

Warnings and Precautions

Warnings

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

after nasal rinsing, especially if fever, nosebleeds or headache are present



Indications and 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)

Helps to loosen thick mucous

Moistens nasal passages

Dosage and Administration

Directions

Adults and children 4 years and over: use 1-2 packets every 8 oz every 2 hours as needed

Children under 4 years: consult a physician

Consult Instructions for Use for proper use





Description

Purpose Nasal Wash

Section 50565-1

Keep out of reach from children

Section 51727-6

Inactive Ingredients

None

Section 51945-4



Section 55105-1

Purpose

Nasal Wash

Section 55106-9

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

Section 59845-8

 Instructions for Use:

Directions: Read through entire section before using for the first time

1. Empty the contents of one Instant Relief Sinus Wash packet into the Sinus Wash Neti Pot. First-time users should start with a 1/2 packet of the dry ingredients. As you become more accustomed to the

system, work up to using 1 full packet. Additional packets may be purchased form 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 solution to run through the nose by gravity.

-Lean over the sink with your head bent down 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 over 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 not 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 after each use with water that has been distilled, sterilized, filtered or previously boiled and leave the pot to air dry completely. The Instant Relief Sinus Wash Neti Pot is

top-rack dishwasher safe.

Section 60561-8

Other Information

-Inspect saline solution packets for integrity

-Do not use if open or torn

-Protect saline solution packets form excessive heat and moisture




Structured Label Content

Indications and Usage (34067-9)

 Uses

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

-Sneezing

-Nasal Stuffiness

-Runny Nose

-Post nasal drip

Removes inhaled irritants (dust, pollen)

Helps to loosen thick mucous

Moistens nasal passages

Dosage and Administration (34068-7)

Directions

Adults and children 4 years and over: use 1-2 packets every 8 oz every 2 hours as needed

Children under 4 years: consult a physician

Consult Instructions for Use for proper use





Warnings and Precautions (34071-1)

Warnings

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

after nasal rinsing, especially if fever, nosebleeds or headache are present



Section 50565-1 (50565-1)

Keep out of reach from children

Section 51727-6 (51727-6)

Inactive Ingredients

None

Section 51945-4 (51945-4)



Section 55105-1 (55105-1)

Purpose

Nasal Wash

Section 55106-9 (55106-9)

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

Section 59845-8 (59845-8)

 Instructions for Use:

Directions: Read through entire section before using for the first time

1. Empty the contents of one Instant Relief Sinus Wash packet into the Sinus Wash Neti Pot. First-time users should start with a 1/2 packet of the dry ingredients. As you become more accustomed to the

system, work up to using 1 full packet. Additional packets may be purchased form 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 solution to run through the nose by gravity.

-Lean over the sink with your head bent down 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 over 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 not 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 after each use with water that has been distilled, sterilized, filtered or previously boiled and leave the pot to air dry completely. The Instant Relief Sinus Wash Neti Pot is

top-rack dishwasher safe.

Section 60561-8 (60561-8)

Other Information

-Inspect saline solution packets for integrity

-Do not use if open or torn

-Protect saline solution packets form excessive heat and moisture




Advanced Ingredient Data


Raw Label Data

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