Label: LACTATED RINGERS injection, solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 18, 2020

If you are a consumer or patient please visit this version.

  • Composition

    Each 100 mL of sterile aquious solution contains:

    Sodium Chloride ............................ 600 mg
    Sodium Lactate .............................. 310 mg
    Potassium Chloride .......................... 30 mg
    Calcium Chloride Dihydrate ............... 20 mg
    Water for Injection .............................. q.s. 

    The Calcium, Potassium and Sodium contents are approximately 2.7, 4.0, and 130 mEq/liter,
    respectively. Total Osomolar concentration: 269 mOsm per liter (calculated). 

  • INDICATIONS

    For the correction of electrolyte depletion, metabolic acidosis and dehydration
    of cattle, calves, horses, sheep and swine. 

  • DOSAGE & ADMINISTRATION:

    May be injected intravenously, subcutaneously or
    intraperitoneally (except in horses) using strict aseptic technique.

    Cattle and Horses: 2 to 5 mL per pound of body weight depending on size and condition
    of animal, repeated 1 to 3 times daily or as needed.

    Swine and Sheep: 2 to 5 mL per pound of body weight depending on size and condition
    of animal, repeated 1 to 3 times daily or as needed.

    If administered subcutaneously divide the dosage into several sites of injection and
    massage points of injection to aid in absorption and help prevent inflammation and/or sloughing. 

  • CAUTION:

    Solution should be warmed to body temperature prior to administration and
    administered at a slow rate. This is a single dose unit. It contains no preservatives. Use entire
    contents when first opened. 

  • WARNING:

    Do not administer to horses by intraperitoneal injection. Do not administer to
    animals with inadequate renal function. Not for use in lactic acidosis. 

  • STORAGE AND HANDLING

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

  • WARNINGS AND PRECAUTIONS

    TAKE TIME OBSERVE LABEL DIRECTIONS

    KEEP OUT OF REACH OF CHILDREN

  • VETERINARY INDICATIONS

    STERILE SOLUTION

    FOR ANIMAL USE ONLY

  • CAUTION:

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    Manufactured by:

    Nova-Tech, Inc.
    Grand Island, NE 68801 USA

    NDC# 65207-803-60

    Nova-Tech®

    Animal Health

    Net Contents:

    1000 mL (33.81 fl oz)

    Lot No.

    Exp. Date

    Assembled in USA

  • PRINCIPAL DISPLAY PANEL

    1000 ml product label1000 ml product label

  • INGREDIENTS AND APPEARANCE
    LACTATED RINGERS 
    lactated ringers injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:65207-803
    Route of AdministrationINTRAVENOUS, SUBCUTANEOUS, INTRAPERITONEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE600 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE310 mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION30 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE20 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65207-803-601000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/18/2020
    Labeler - Nova-Tech, Inc. (196078976)
    Registrant - Nova-Tech, Inc. (196078976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova-Tech, Inc.196078976manufacture, api manufacture