SPL v8
SPL
SPL Set ID c3cd7f0f-8d70-23af-e053-2a95a90a569b
Route
HEMODIALYSIS
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (8.4 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-03-30
Description

This is a Hemodialysis-Grade Sodium Bicarbonate Solution. This solution already diluted 1:27:57 with purified water (standard 13959:2014), provides: Sodium: 35.0 mEq/l Bicarbonate: 35.0 mEq/l Each 1000 mL of this solution contains: Sodium bicarbonate USP, hemodialysis grade: 84.0 g Purified water (standard ISO 13959:2014), csp: 1000 mL

Purpose

For use only with 3-pump hemodialysis machines.

Medication Information

Purpose

For use only with 3-pump hemodialysis machines.

Dosage and Administration

For use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water.

Description

This is a Hemodialysis-Grade Sodium Bicarbonate Solution. This solution already diluted 1:27:57 with purified water (standard 13959:2014), provides: Sodium: 35.0 mEq/l Bicarbonate: 35.0 mEq/l Each 1000 mL of this solution contains: Sodium bicarbonate USP, hemodialysis grade: 84.0 g Purified water (standard ISO 13959:2014), csp: 1000 mL

Use

Use oly with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standard ISO 13959:2014) IN A RATIO 1:1.23:32.77.

Section 42229-5

This is a Hemodialysis-Grade Sodium Bicarbonate Solution.

This solution already diluted 1:27:57 with purified water (standard 13959:2014), provides:

Sodium: 35.0 mEq/l

Bicarbonate: 35.0 mEq/l

Each 1000 mL of this solution contains:

Sodium bicarbonate USP, hemodialysis grade: 84.0 g

Purified water (standard ISO 13959:2014), csp: 1000 mL

Section 43683-2

Use only with 3-pump hemodialysis machines.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

If not all of the contents are used, discard the excess.

Warnings

The solution should be transparent and colorless. Do not use if cloudy or with broken seal. If not all of the contents are used, discard the excess. Keep at room temperature.

Do Not Use
  • If cloudy or with broken seal.
Other Information
  • Keep at room temperature.
Active Ingredient(s)

Sodium Bicarbonate: Antiseptic

Inactive Ingredients

Purified water (standard ISO 13959:2014)

Package Label Principal Display Panel

3785 mL NDC: 81943-502-01

Structured Label Content

Use

Use oly with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standard ISO 13959:2014) IN A RATIO 1:1.23:32.77.

Dosage and Administration (34068-7)

For use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water.

Section 42229-5 (42229-5)

This is a Hemodialysis-Grade Sodium Bicarbonate Solution.

This solution already diluted 1:27:57 with purified water (standard 13959:2014), provides:

Sodium: 35.0 mEq/l

Bicarbonate: 35.0 mEq/l

Each 1000 mL of this solution contains:

Sodium bicarbonate USP, hemodialysis grade: 84.0 g

Purified water (standard ISO 13959:2014), csp: 1000 mL

Section 43683-2 (43683-2)

Use only with 3-pump hemodialysis machines.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

If not all of the contents are used, discard the excess.

Purpose

For use only with 3-pump hemodialysis machines.

Warnings

The solution should be transparent and colorless. Do not use if cloudy or with broken seal. If not all of the contents are used, discard the excess. Keep at room temperature.

Do Not Use (Do not use)
  • If cloudy or with broken seal.
Other Information (Other information)
  • Keep at room temperature.
Active Ingredient(s)

Sodium Bicarbonate: Antiseptic

Inactive Ingredients (Inactive ingredients)

Purified water (standard ISO 13959:2014)

Package Label Principal Display Panel (Package Label - Principal Display Panel)

3785 mL NDC: 81943-502-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:27.508482 · Updated: 2026-03-14T23:13:34.159935