SIMPLY SALINE COMFORT FLOW SINUS WASH- sinus wash powder, for solution

Simply Saline Comfort Flow Sinus wash by

Drug Labeling and Warnings

Simply Saline Comfort Flow Sinus wash by is a Otc medication manufactured, distributed, or labeled by GURUNANDA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sodium Bicarbonate USP 515 mg

Sodium Chloride USP 1685 mg

Purpose

Nasal Wash

Uses

• Restores vital moisture to provide prompt relief for dry , crusted and inflamed nasal membranes due to chronic sinusitis, colds, low humidity, overuse of nasal decongestant drops and sprays, allergies, minor nose bleeds and other minor nasal irritations.
• Temporarily relieves nasal stuffiness.
• Reduces swelling of nasal passages; shrinks swollen membranes.
• Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure.

Warnings

• Do not exceed recommended dosage.
• This product may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge.
• The use of this container by more than one person may spread infection.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Directions

• Adults and children 4 years and over : Use 1-2 packets per 240 ml up to every 2 hours as needed
• Children under 4 years : Consult a physician

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

Inactive Ingredients

None

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMPLY SALINE COMFORT FLOW SINUS WASH 
sinus wash powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70708-270
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	515 mg  in 2200 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	1685 mg  in 2200 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (WHITE CRYSTALLINE GRANULE POWDER)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70708-270-50	50 in 1 BOX	10/01/2022
1		2200 mg in 1 POUCH; Type 1: Convenience Kit of Co-Package
2	NDC: 70708-270-10	10 in 1 BOX	09/01/2022
2		2200 mg in 1 POUCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/15/2020

Labeler - GURUNANDA, LLC (079671169)