Sodium Chloride Tablets, Usp

SPL v1

SPL

SPL Set ID 42870188-b1d7-4934-a6c0-310530497dac

Route

ORAL

Published

Effective Date 2025-11-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chloride Ion (1000 mg)

Identifiers & Packaging

Pill Appearance

Imprint: RB51 Shape: round Color: white Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-06

Description

Active Ingredient (in each tablet) Sodium Chloride, USP 1.0 gram

Purpose

Electrolyte Replenisher

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses:

for the preparation of normal isotonic solution of sodium chloride
as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration
any alternative use as directed by a physician

Purpose

Electrolyte Replenisher

Dosage and Administration

Directions

to make isotonic solution of sodium chloride, dissolve one tablet in 120 mL (four ounces) of distilled water and use as directed by a physician
if used as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as directed by physician

Description

Active Ingredient (in each tablet) Sodium Chloride, USP 1.0 gram

Section 42229-5

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Issued: 10/2025

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours

Section 50569-3

Ask a physician before use if you have a sodium restricted diet due to multiple organ diseases

Section 50570-1

Do not use without consulting a physician

Section 51945-4

Sodium Chloride Tablets, USP

1 Gram

Normal salt tablets
For solution or oral use

100 Tablets

Section 53413-1

Questions or comments?

Call 1-844-474-7464

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Section 60561-8

Other information:

each tablet contains: sodium 394 mg
store at room temperature 15ºC to 30ºC (59ºF to 86ºF)
Product does not contain any inactive ingredients
Supplied as round white tablet imprinted with RB51

Other Ingredients

None

Tamper Evident: Do Not Use If Imrinted Safety Seal Under Cap Is Broken Or Missing

Active Ingredient (in each tablet)

Sodium Chloride, USP 1.0 gram

Structured Label Content

Indications and Usage (34067-9)

Uses:

for the preparation of normal isotonic solution of sodium chloride
as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration
any alternative use as directed by a physician

Dosage and Administration (34068-7)

Directions

to make isotonic solution of sodium chloride, dissolve one tablet in 120 mL (four ounces) of distilled water and use as directed by a physician
if used as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as directed by physician

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Issued: 10/2025

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours

Section 50569-3 (50569-3)

Ask a physician before use if you have a sodium restricted diet due to multiple organ diseases

Section 50570-1 (50570-1)

Do not use without consulting a physician

Section 51945-4 (51945-4)

Sodium Chloride Tablets, USP

1 Gram

Normal salt tablets
For solution or oral use

100 Tablets

Section 53413-1 (53413-1)

Questions or comments?

Call 1-844-474-7464

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Section 60561-8 (60561-8)

Other information:

each tablet contains: sodium 394 mg
store at room temperature 15ºC to 30ºC (59ºF to 86ºF)
Product does not contain any inactive ingredients
Supplied as round white tablet imprinted with RB51

Purpose

Electrolyte Replenisher

Other Ingredients

None

Tamper Evident: Do Not Use If Imrinted Safety Seal Under Cap Is Broken Or Missing (TAMPER EVIDENT: DO NOT USE IF IMRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING)

Active Ingredient (in each tablet)

Sodium Chloride, USP 1.0 gram

Advanced Ingredient Data

[{"name": "CHLORIDE ION", "unii": "Q32ZN48698", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: for the preparation of normal isotonic solution of sodium chloride as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration any alternative use as directed by a physician", "34068-7": "Directions to make isotonic solution of sodium chloride, dissolve one tablet in 120 mL (four ounces) of distilled water and use as directed by a physician if used as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as directed by physician", "34071-1": "Warnings", "42229-5": "Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 10/2025", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours", "50569-3": "Ask a physician before use if you have a sodium restricted diet due to multiple organ diseases", "50570-1": "Do not use without consulting a physician", "51945-4": "Sodium Chloride Tablets, USP 1 Gram Normal salt tablets For solution or oral use 100 Tablets", "53413-1": "Questions or comments? Call 1-844-474-7464", "53414-9": "If pregnant or breast-feeding, ask a health professional before use", "60561-8": "Other information: each tablet contains: sodium 394 mg store at room temperature 15ºC to 30ºC (59ºF to 86ºF) Product does not contain any inactive ingredients Supplied as round white tablet imprinted with RB51", "Purpose": "Electrolyte Replenisher", "Other Ingredients": "None", "TAMPER EVIDENT: DO NOT USE IF IMRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING": "Active Ingredient (in each tablet) Sodium Chloride, USP 1.0 gram"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:58.671273 · Updated: 2026-03-14T23:13:29.977510