SPL v8
SPL
SPL Set ID 9e90c1c1-4dcd-106e-e053-2995a90afd15
Route
NASAL
Published
Effective Date 2020-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (0.515 g) Sodium Cation (1.685 g)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-06-15

Description

Sodium Bicarbonate USP 515mg Sodium Chloride USP 1685 mg

Purpose

Nasal Wash


Medication Information

Purpose

Nasal Wash

Description

Sodium Bicarbonate USP 515mg Sodium Chloride USP 1685 mg

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.
Section 50565-1

Keep out of reach of children.

Section 51945-4

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.
Directions
  • Adults and children 4 years and over: Use 1-2 packets per 240 ml upto 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 oe box for lot# and expiration date
Active Ingredients

Sodium Bicarbonate USP 515mg

Sodium Chloride USP 1685 mg

Inactive Ingredients

None


Structured Label Content

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.
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Nasal Wash

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.
Directions
  • Adults and children 4 years and over: Use 1-2 packets per 240 ml upto 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 oe box for lot# and expiration date
Active Ingredients

Sodium Bicarbonate USP 515mg

Sodium Chloride USP 1685 mg

Inactive Ingredients

None


Advanced Ingredient Data


Raw Label Data

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