OTC Medication Information: Simply Saline Comfort Flow Sinus Wash

SIMPLY SALINE COMFORT FLOW SINUS WASH- sodium bicarbonate and sodium chloride powder, for solution
GURUNANDA, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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 10 ct

PRINCIPAL DISPLAY PANEL 50 ctPRINCIPAL DISPLAY PANEL 10 ctPRINCIPAL DISPLAY PANEL 50 ct
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 515 mg in 2200 mg
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 1685 mg in 2200 mg
Inactive Ingredients
Ingredient Name Strength
WATER
Product Characteristics
Color white (WHITE CRYSTALLINE GRANULE POWDER) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70708-270-50 50 POUCH in 1 BOX contains a POUCH
1 2200 mg in 1 POUCH This package is contained within the BOX (70708-270-50)
2 NDC:70708-270-10 10 POUCH in 1 BOX contains a POUCH
2 2200 mg in 1 POUCH This package is contained within the BOX (70708-270-10)
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)

Revised: 09/2022 GURUNANDA, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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