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Animal NDC 57319-554-08 Hypertonic Saline

Animal Product Information

Field Name Field Value
Animal NDC Code 57319-554-08
Proprietary Name Hypertonic Saline What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Hypertonic Saline What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Phoenix
Product Type Prescription Animal Drug
Usage Information
    For use in replacement therapyof sodium, chloride and water which maybecome depleted in many diseases.
Active Ingredient(s)
  • Sodium Chloride
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Hypertonic Saline Images

Hypertonic Saline Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Indications:



For use in replacement therapy
of sodium, chloride and water which may
become depleted in many diseases.


Caution:



This product contains no pre-
servatives. Use entire contents when first
opened. Discard any unused solution.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.


Dosage And Administration:



Warm to
body temperature and administer slowly by
intravenous or subcutaneous injection. The
amount and rate of administration must be
judged by the veterinarian in relation to the 
condition being treated and the clinical
response of the animal, being careful to avoid
overhydration.


Veterinary Indications



FOR ANIMAL USE ONLY


Warnings And Precautions



KEEP OUT OF REACH OF CHILDREN


Composition:



Each 100 mL of sterile
aqueous solution contains:
Sodium Chloride ................... 7.2 g

Milliequivalents per liter

Cations
Sodium ......................... 1232 mEq/L
Anions
Chloride ........................ 1232 mEq/L

Total osmolarity is 2464 milliosmoles per liter.


Storage And Handling



Store between 15°C and 30°C (59°F and 86°F)


General Precautions



TAKE TIME OBSERVE LABEL DIRECTIONS


Information For Owners/Caregivers



Manufactured by
Nova-Tech, Inc.
Grand Island, NE 68801

RMS 92-548

18-806-60

Rev. 06-10

NDC 57319-554-08

Sterile - Preservative Free

Net Contents: 1000 mL

Manufactured for:
Clipper Distributing Company, LLC
St. Joseph, MO 64507

Trademarks are property of
Clipper Distributing Company, LLC

Lot No.

Exp. Date


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.