Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID e3fc498d-2bdc-4464-b893-58e8663b067b

Route

ORAL

Published

Effective Date 2013-05-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Sodium Cation (700 mg) Bicarbonate Ion (2300 mg)

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2013-04-01

Description

Inactive Ingredients None

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Temporarily relieves symptoms associated with sinusitis, colds, flu or allergies

Sneezing

Runny nose

Nasal stuffiness

Post nasal drip

Removes inhaled irritants (dust, pollen)

Promotes nasal and sinus drainage

Helps reduce swelling of nasal membranes

Dosage and Administration

Directions

Adults and children 4 years and over: 1-2 packets every 2 hours as needed

Children under 4 years: Consult a doctor

Consult Instructions for Use for proper use

Description

Inactive Ingredients None

Section 50565-1

Keep out of reach from children

Section 51727-6

Inactive Ingredients

None

Section 51945-4

Section 55105-1

Purpose

Nasal wash

Section 55106-9

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 1200 mg

Section 60561-8

Other Information

Inspect saline solution packets for integrity

Do not use if open or torn

Protect saline solution packets from excessive heat and moisture

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves symptoms associated with sinusitis, colds, flu or allergies

Sneezing

Runny nose

Nasal stuffiness

Post nasal drip

Removes inhaled irritants (dust, pollen)

Promotes nasal and sinus drainage

Helps reduce swelling of nasal membranes

Dosage and Administration (34068-7)

Directions

Adults and children 4 years and over: 1-2 packets every 2 hours as needed

Children under 4 years: Consult a doctor

Consult Instructions for Use for proper use

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach from children

Section 51727-6 (51727-6)

Inactive Ingredients

None

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Nasal wash

Section 55106-9 (55106-9)

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 1200 mg

Section 60561-8 (60561-8)

Other Information

Inspect saline solution packets for integrity

Do not use if open or torn

Protect saline solution packets from excessive heat and moisture

Advanced Ingredient Data

[{"name": "SODIUM CATION", "unii": "LYR4M0NH37", "classCode": "ACTIB", "strengthNumerator": "700", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "BICARBONATE ION", "unii": "HN1ZRA3Q20", "classCode": "ACTIB", "strengthNumerator": "2300", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Temporarily relieves symptoms associated with sinusitis, colds, flu or allergies Sneezing Runny nose Nasal stuffiness Post nasal drip Removes inhaled irritants (dust, pollen) Promotes nasal and sinus drainage Helps reduce swelling of nasal membranes", "34068-7": "Directions Adults and children 4 years and over: 1-2 packets every 2 hours as needed Children under 4 years: Consult a doctor Consult Instructions for Use for proper use", "34071-1": "Warnings For external use only", "50565-1": "Keep out of reach from children", "51727-6": "Inactive Ingredients None", "55105-1": "Purpose Nasal wash", "55106-9": "Active Ingredients (in each packet) Sodium Bicarbonate USP 700 mg Sodium Chloride USP 1200 mg", "60561-8": "Other Information Inspect saline solution packets for integrity Do not use if open or torn Protect saline solution packets from excessive heat and moisture"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:37.885852 · Updated: 2026-03-14T22:53:29.712463