SPL v7
SPL
SPL Set ID c33bf872-54aa-45e0-9e40-a6565a13f198
Route
NASAL
Published
Effective Date 2015-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

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

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

-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 -1 packet  per 4 fl oz (120 mL) up to every 2 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 42229-5

Important Note: SinuCleanse Saline Packets contain 3 grams of

pharmaceutical grade salt. Using the calculations in the chart, you can

prepare either an Isotonic or Hypertonic Solution. Since contents of other

manufacturer's Salt Packets may vary, please check with their directions

for Isotonic or Hypertonic use.

Section 50565-1

Keep out of reach of children

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

-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 -1 packet  per 4 fl oz (120 mL) up to every 2 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 42229-5 (42229-5)

Important Note: SinuCleanse Saline Packets contain 3 grams of

pharmaceutical grade salt. Using the calculations in the chart, you can

prepare either an Isotonic or Hypertonic Solution. Since contents of other

manufacturer's Salt Packets may vary, please check with their directions

for Isotonic or Hypertonic use.

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 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)