OTC Medication Information: Sodium Chloride

SODIUM CHLORIDE- sodium chloride tablet
Wittman Pharma, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

None

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

Keep out of reach of children.

Purpose

Electrolyte Replenisher

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

Label
(click image for full-size original)
SODIUM CHLORIDE
normal salt tablets tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:83335-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 1 g in 1 g
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code SC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:83335-002-01 100 g in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 08/09/2023
Labeler — Wittman Pharma, Inc. (830980947)
Registrant — Wittman Pharma, Inc. (830980947)
Establishment
Name Address ID/FEI Operations
Wittman Pharma, Inc. 830980947 label (83335-002), analysis (83335-002), manufacture (83335-002)

Revised: 10/2023 Wittman Pharma, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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