Sodium Chloride
FDA Label NDC 83335-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wittman Pharma, Inc. for the product Sodium Chloride (NDC 83335-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, drug facts, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Dosage & Administration

→ Warnings

→ Inactive Ingredient

→ Indications & Usage

→ Otc - Keep Out Of Reach Of Children

→ Otc - Purpose

→ Otc - Active Ingredient

→ Drug Facts

Dosage & Administration

Directions

to make isontonic 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 your physician.

Warnings

Do not use without consulting a physician

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

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

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

Keep out of reach of children.

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

Inactive Ingredient

None

Indications & 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

Purpose

Electrolyte Replenisher

Otc - Active Ingredient

Active ingredient (in each tablet)

Sodium Chloride, USP 1.0 gram

Drug Facts

Active ingredient (in each tablet)

Sodium Chloride, USP 1.0 gram

Purpose

Electrolyte Replenisher

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

Warnings

Do not use without consulting a physician

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

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

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

Keep out of reach of children.

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

Directions

to make isontonic 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 your physician.

Other information

each tablet contains: sodium 394 mg

store at room temperature 15°-30°C (59°-86°F)

product does not contain any inactive ingredients

Questions or comments?

Call 1-352-549-9917 M-F 9am - 5pm EST

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