SPL v8
SPL
SPL Set ID 9e905ecb-d4d5-514a-e053-2a95a90adfbb
Route
NASAL
Published
Effective Date 2020-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Sodium Bicarbonate USP 515 mg Sodium Chloride USP 1685 mg

Purpose

Nasal Wash


Medication Information

Purpose

Nasal Wash

Description

Sodium Bicarbonate USP 515 mg 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, overdose 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 51727-6

None

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 chldren 4 years and over: Use 1-2 packets per 240ml water 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
Active Ingredients(in Each Packet)

Sodium Bicarbonate USP 515 mg

Sodium Chloride USP 1685 mg


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, overdose 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 51727-6 (51727-6)

None

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 chldren 4 years and over: Use 1-2 packets per 240ml water 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
Active Ingredients(in Each Packet) (Active Ingredients(in each packet))

Sodium Bicarbonate USP 515 mg

Sodium Chloride USP 1685 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)