Lactated Ringers: Product Information

LACTATED RINGERS — sodium chloride, sodium lactate, potassium chloride and calcium chloride injection, solution
A & G Pharmaceuticals, Inc.

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.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
NET CONTENTS: 1000 mL

INDICATIONS:

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

DOSAGE AND 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.

Store between 15 degrees C — 30 degrees C (59 degrees F — 86 degrees F)

EACH 100 mL 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 Osmolar Concentration: 269 mOsmol per liter (calculated).

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.

Manufactured by

Nova-Tech, Inc.

Grand Island, NE 68801

TAKE TIME OBSERVE LABEL DIRECTIONS

Iss. 04-09

Manufactured for:

A and G Pharmaceuticals

Clarksburg, NJ 08510

LACTATED RINGERS lactated ringers injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57699-803 Route of Administration INTRAVENOUS, SUBCUTANEOUS, INTRAPERITONEAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (Sodium Cation) Sodium Chloride 600 mg in 1000 mL Sodium Lactate (Sodium Cation) Sodium Lactate 310 mg in 1000 mL Potassium Chloride (Potassium Cation) Potassium Chloride 30 mg in 1000 mL Calcium Chloride (Calcium Cation) Calcium Chloride 20 mg in 1000 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57699-803-60 1000 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/25/2013

Labeler — A & G Pharmaceuticals, Inc. (182147033)

Registrant — A & G Pharmaceuticals, Inc. (182147033)

Establishment
Name	Address	ID/FEI	Operations
Nova-Tech Inc.		196078976	manufacture

Establishment
Name	Address	ID/FEI	Operations
K+S KALI GmbH		507531213	api manufacture

Revised: 02/2015 A & G Pharmaceuticals, Inc.