Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID e6ade9f5-3112-4c5f-a5d9-146a12e83961
Route
NASAL
Published
Effective Date 2014-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Do not use unfiltered tap water. see instructions inside box for proper water sources

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)

Removes nasal and sinus drainage

Helps reduce swelling of nasal membranes

Moisturizes dry nasal passages

Dosage and Administration

Directions

Adults and children 4 years and over: Use 1-2 packets per 8 fl oz (240 mL) up to every two hours as needed.





Children under 4 years: Consult a physician

See enclosed instruction sheet for complete directions and proper use.

Description

Purpose Nasal Wash

Section 50565-1

Keep out of reach of 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 of the Squeeze Bottle:

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

1. Remove the cap from the squeeze bottle.

2. Pour the pre-mixed saline dry into the Squeeze Bottle. First-time users

should start with 1 packet of the saline dry ingredients. As you become more accustomed to the system, work up to using 2 full packets,

Additional packets may be purchased from your nearest pharmacy.

3. Fill the bottle with proper water* leaving approximately 1/2 inch of air at the top of the bottle.

This makes 1 cup (8 oz) of solution.

4. Tighten the cap on the bottle securely, place one finger over the tip of the cap and and gently shake the bottle until

the dry ingredients have completely dissolved.

5. Lean over the sink with your head bent so you are looking directly directly into the basin. Place the tip of the cap up to the right nostril and gently insert the tip

so that it forms a comfortable seal. Aim the tip at the back of your head, not at the top of your head.

6. Squeeze the bottle gently so that the solution enters the right nostril. Do not inhale or "snort" the solution into your nose - breathe through your mouth.

7. In a few moments the solution will begin to drain out of the left nostril. Continue to squeeze the bottle gently until you have

used approximately half of the solution.

8. Remove the tip of the bottle from your nostril, then exhale through both nostrils to clear them of

excess mucus and solution. Gently blow your nose into a tissue.

9. Repeat the procedure on the left nostril with the remaining solution.

10. A small amount of the solution will remain in the bottom of the bottle. Discard the remaining solution.

11. Thoroughly rinse the bottle after each use with water that has been distilled, sterilized,

filtered or previously boiled and leave the bottle open to air dry completely. The Squeeze Bottle is

top-rack dishwasher safe.


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)

Removes nasal and sinus drainage

Helps reduce swelling of nasal membranes

Moisturizes dry nasal passages

Dosage and Administration (34068-7)

Directions

Adults and children 4 years and over: Use 1-2 packets per 8 fl oz (240 mL) up to every two hours as needed.





Children under 4 years: Consult a physician

See enclosed instruction sheet for complete directions and proper use.

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

Keep out of reach of 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 of the Squeeze Bottle:

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

1. Remove the cap from the squeeze bottle.

2. Pour the pre-mixed saline dry into the Squeeze Bottle. First-time users

should start with 1 packet of the saline dry ingredients. As you become more accustomed to the system, work up to using 2 full packets,

Additional packets may be purchased from your nearest pharmacy.

3. Fill the bottle with proper water* leaving approximately 1/2 inch of air at the top of the bottle.

This makes 1 cup (8 oz) of solution.

4. Tighten the cap on the bottle securely, place one finger over the tip of the cap and and gently shake the bottle until

the dry ingredients have completely dissolved.

5. Lean over the sink with your head bent so you are looking directly directly into the basin. Place the tip of the cap up to the right nostril and gently insert the tip

so that it forms a comfortable seal. Aim the tip at the back of your head, not at the top of your head.

6. Squeeze the bottle gently so that the solution enters the right nostril. Do not inhale or "snort" the solution into your nose - breathe through your mouth.

7. In a few moments the solution will begin to drain out of the left nostril. Continue to squeeze the bottle gently until you have

used approximately half of the solution.

8. Remove the tip of the bottle from your nostril, then exhale through both nostrils to clear them of

excess mucus and solution. Gently blow your nose into a tissue.

9. Repeat the procedure on the left nostril with the remaining solution.

10. A small amount of the solution will remain in the bottom of the bottle. Discard the remaining solution.

11. Thoroughly rinse the bottle after each use with water that has been distilled, sterilized,

filtered or previously boiled and leave the bottle open to air dry completely. The Squeeze Bottle is

top-rack dishwasher safe.


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