Premixed saline packets

Manufacturer
Shenzhen Kerui lnt’l Trading Co., Ltd | Shenzhen Kerui Int'l trading co., ltd.
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:19

Label at a glance#

ProductPremixed saline packets
Active ingredientSODIUM BICARBONATE, SODIUM CHLORIDE
Label structure8 sections

Indications and uses

Relieve Nasal Passages From: ■Nasal symptoms from sinusitis, cold, flu ■Nasal allergies, dryness and Hay fever ■Sneezing, runny nose, nasal stuffiness ■lPost nasal drip and nasal congestion ■Removes nasal irritants (dust, pollen, animal dander, smoke etc) ■Promotes nasal and sinus drainage l■Moisturizes dry nasal passages ■Helps reduce swelling of nasal membranes

Dosage and administration

Adults and children 4 years and over: use 1-2 packets per 8 fl oz (240ml) up to every 2 hours as needed Children under 4 years: Consult a physician Mixing one saline packet to 8 fl oz (240ml) of water creates an Isotonic saline solution (Hypertonic with 2 saline packets) that is PH balanced and preservative free. Isotonic solution 1 saline packet per 8 fl oz (240 ml) Hypertonic solution 2 saline packets per 8 fl o...

Storage and handling

Store in a cool and dry place.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride USP 2300mg

Sodium Bicarbonate USP 700mg

Purpose

OTC - PURPOSE SECTION

Nasal Wash

Uses

INDICATIONS & USAGE SECTION

Relieve Nasal Passages From:

■Nasal symptoms from sinusitis, cold, flu ■Nasal allergies, dryness and Hay fever ■Sneezing, runny nose, nasal stuffiness

■lPost nasal drip and nasal congestion ■Removes nasal irritants (dust, pollen, animal dander, smoke etc)

■Promotes nasal and sinus drainage l■Moisturizes dry nasal passages ■Helps reduce swelling of nasal membranes

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

■ if saline packet is open, torn, or expired.

■ with fully blocked nasal passages or during ear infection or blockage.

■ unfiltered tap water, unless it has been previously boiled for at least five minutes and then cooled to lukewarm or body temperature, as boiling sterilizes the water. Other choice are distilled, micro-filtered (through 0.2 micron), reverse osmosis filtered, or commercially bottled water.

When using this product

OTC - WHEN USING SECTION

Wash hands before using

Stop use and ask a doctor

OTC - STOP USE SECTION

if discomfort or unrelieved symptoms occur.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 4 years and over:

use 1-2 packets per 8 fl oz (240ml) up to every 2 hours as needed

Children under 4 years:

Consult a physician

Mixing one saline packet to 8 fl oz (240ml) of water creates an Isotonic saline solution (Hypertonic with 2 saline packets) that is PH balanced and preservative free.

Isotonic solution

1 saline packet per 8 fl oz (240 ml)

Hypertonic solution

2 saline packets per 8 fl oz (240 ml)

An Isotonic solution has a gentle salt concentration of 9 mg of Sodium Chloride per ml of water, similar to your body's salt level. It can be more comfortable for some initially than a stronger Hypertonic solution.

A Hypertonic solution has a higher salt concentration, akin to ocean water's salt content.

Other information

STORAGE AND HANDLING SECTION

Store in a cool and dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

None

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

001-001-

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionPSN2
1542919sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal SolutionSCD2
1542919NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83879-001-01Premixed saline packets3000 mg in 1 BAGGRANULE, FOR SOLUTION30002
83879-001-01Premixed saline packets100 in 1 BOXGRANULE, FOR SOLUTION1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83879-001PREMIXED SALINE PACKETS (SODIUM CHLORIDE, SODIUM BICARBONATE) GRANULE, FOR SOLUTION [SHENZHEN KERUI LNT’L TRADING CO., LTD]2Current NDC, 2 package rows20250110_0d11e07b-c137-6efc-e063-6394a90a6bba.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83879-00183879-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOACTIB
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
ndc (package): 83879-001-01
ndc (product): 83879-001
ndc11 (package): 83879000101
spl id: 2b42cc1e-2017-8753-e063-6394a90aad5f
spl set id: 0d11e07b-c137-6efc-e063-6394a90a6bba

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.