SPL v9
SPL
SPL Set ID ff4df6c5-c85f-406a-89d7-8c2853fd5e10
Route
NASAL
Published
Effective Date 2015-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (22.2 mg) Sodium Cation (77.8 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-02-01

Description

Active Ingredients (in each packet) Sodium Bicarbonate USP 700 mg Sodium Chloride USP 2300 mg


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.

Do not use if nasal passages are completely blocked or if you have

an ear infection or blocked ears.

Indications and Usage

Uses

Temporarily relieves symptoms associated with

sinusitis, cold, flu or allergies:

-Sneezing

-Runny nose

-Nasal stuffiness

-Post nasal drip

-Removes inhaled irritants (dust, pollen)

-Promotes 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 - 1 packet per 4 fl oz (120 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

Active Ingredients (in each packet) Sodium Bicarbonate USP 700 mg Sodium Chloride USP 2300 mg

Section 50565-1

Keep out of reach of children

Section 50567-7

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

Section 51727-6

Inactive Ingredients

None

Section 51945-4

Section 53413-1

Questions?

1-888-547-5492

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 60561-8

Other Information

-Inspect saline packets for integrity

-Do not use saline packets if open or torn

-Protect saline packets from excessive heat and moisture

-See saline packets or box for lot # and expiration date


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves symptoms associated with

sinusitis, cold, flu or allergies:

-Sneezing

-Runny nose

-Nasal stuffiness

-Post nasal drip

-Removes inhaled irritants (dust, pollen)

-Promotes 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 - 1 packet per 4 fl oz (120 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.

Do not use if nasal passages are completely blocked or if you have

an ear infection or blocked ears.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

Inactive Ingredients

None

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

1-888-547-5492

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 60561-8 (60561-8)

Other Information

-Inspect saline packets for integrity

-Do not use saline packets if open or torn

-Protect saline packets from excessive heat and moisture

-See saline packets or box for lot # and expiration date


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)