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| Product NDC Code | 70369-007 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sodium chloride normal salt |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET | ||||||||
| RxCUI drug identifier | 313009 | ||||||||
| Application Number | part349 | ||||||||
| Labeler Name | Citragen Pharmaceuticals Inc | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Sodium Chloride Normal Salt
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each tablet) Sodium Chloride, USP 1.0 gram
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Information about the drug product’s indications for use.Purpose Electrolyte Replenisher
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Normal Salt Sodium Chloride SODIUM CHLORIDE CHLORIDE ION CG007
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.CitraGen Pharmaceuticals, Inc. NDC: 70369‐007‐02 Sodium Chloride Tablets, USP 1 gram Normal salt tablets For solution or oral use 500 Tablets THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN 500's Bottle Label
CitraGen Pharmaceuticals, Inc. NDC: 70369‐007‐03 Sodium Chloride Tablets, USP 1 gram Normal salt tablets For solution or oral use 100 Tablets 100's Bottle Label
CitraGen Pharmaceuticals, Inc. NDC: 70369‐007‐07 Sodium Chloride Tablets, USP 1 gram Normal salt tablets For solution or oral use 300 Tablets 300s Pack Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: CitraGen Pharmaceuticals, Inc., Fremont, CA 94538. www.citragenpharma.com Rev. 02/19 R-00
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a physician before use if you have a sodium restricted diet due to multiple organ diseases
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use without consulting a physician
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API