Leader 100ct Refills

Leader 100ct Refills
SPL v12
SPL
SPL Set ID fb192a6d-318e-4d2b-89b6-42ac023e4fbd
Route
NASAL
Published
Effective Date 2017-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (700 mg) Sodium Cation (2300 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-04-01
Description

Active Ingredients (in each packet) Sodium Bicarbonate USP 700 mg Sodium Chloride USP 2300 mg

Medication Information

Warnings and Precautions

Warnings

• Stop use and ask a  doctor if washing is uncomfortable or symptoms are not relieved.

• Do not use unfiltered tap water, see instructions inside box for for proper water sources.

• Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.

Indications and Usage

Uses

Temporarily relieves symptoms associated with sinusitis, cold, 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

•Moisturizes dry nasal passages

Dosage and Administration

Directions

Adults and children

4 years and over:

 Use 1-2 packets per 8 fl oz(240 mL)

up to every 2 hours as needed
 Children under 4 years:  Consult a physician
 See enclosed instruction sheetfor complete directions and proper use

Description

Active Ingredients (in each packet) Sodium Bicarbonate USP 700 mg Sodium Chloride USP 2300 mg

Section 42230-3

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients

None

Section 51945-4

Section 53413-1

Questions?

1-888-547-5492

Section 55105-1

Purpose

Nasal Wash

Section 55106-9

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves symptoms associated with sinusitis, cold, 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

•Moisturizes dry nasal passages

Dosage and Administration (34068-7)

Directions

Adults and children

4 years and over:

 Use 1-2 packets per 8 fl oz(240 mL)

up to every 2 hours as needed
 Children under 4 years:  Consult a physician
 See enclosed instruction sheetfor complete directions and proper use

Warnings and Precautions (34071-1)

Warnings

• Stop use and ask a  doctor if washing is uncomfortable or symptoms are not relieved.

• Do not use unfiltered tap water, see instructions inside box for for proper water sources.

• Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.

Section 42230-3 (42230-3)

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients

None

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

1-888-547-5492

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 2300 mg

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.804860 · Updated: 2026-03-14T23:09:18.179019