RE-COVR™ (tripelennamine hydrochloride injection) 20 mg per mL Antihistamine

Manufacturer
Kinetic Technologies, LLC
Effective date
2022-02-24
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:41:20

Label at a glance#

ProductRE-COVR
Active ingredientTRIPELENNAMINE HYDROCHLORIDE
Label structure16 sections

Dosage and administration

Horses: Administer intramuscularly only at a dose of 0.5 mg per lb of body weight (2.5 mL for each 100 lbs of body weight).  This dose may be repeated in 6-12 hours if necessary. Cattle:   Administer intravenously or intramuscularly at a dose of 0.5 mg per lb of body weight (2.5 mL for each 100 lbs of body weight).  This dose may be repeated in 6-12 hours if necessary.  The intravenous route of administration may ...

Storage and handling

Store at 20°C to 25°C (68°F - 77°F), excursions permitted between 15°C to 30°C (59°F and 86°F).  Keep from freezing.  Protect from light.

Label contents#

Full prescribing information#

DESCRIPTION:

DESCRIPTION SECTION

Tripelennamine hydrochloride is a white, crystalline material which is stable, nonhygroscopic, and readily soluble in water.  Tripelennamine hydrochloride is characterized by its capacity to antagonize many of the pharmacologic effects of histamine.  RE-COVR™ (tripelennamine hydrochloride injection) is supplied as a sterile solution in multiple dose vials containing 20 mg of tripelennamine hydrochloride, USP per mL, and may contain sodium hydroxide for pH adjustment.

INDICATIONS:

VETERINARY INDICATIONS SECTION

For use in horses and cattle in conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.  Not for use in beef calves less than 2 months of age, dairy calves, and veal calves.  See package onsert for complete indications for use.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Horses: Administer intramuscularly only at a dose of 0.5 mg per lb of body weight (2.5 mL for each 100 lbs of body weight).  This dose may be repeated in 6-12 hours if necessary.

Cattle:  Administer intravenously or intramuscularly at a dose of 0.5 mg per lb of body weight (2.5 mL for each 100 lbs of body weight).  This dose may be repeated in 6-12 hours if necessary.  The intravenous route of administration may provide a more rapid onset of action.  Use aseptic technique to administer RE-COVR™ (tripelennamine hydrochloride injection).

Warm the solution to near body temperature prior to administration.  Intramuscular injection should be made into the heavy musculature of the hind leg or cervical area.

While venomous snake bites have been treated with antihistaminic drugs, other conjunctive therapy is required because of toxic reactions associated with the protein complex of venom.

Do not puncture the stopper more than 30 times, use within the 24-month product expiry.

STORAGE AND HANDLING:

STORAGE AND HANDLING SECTION

Store at 20°C to 25°C (68°F - 77°F), excursions permitted between 15°C to 30°C (59°F and 86°F).  Keep from freezing.  Protect from light.

SPL UNCLASSIFIED SECTION

Manufactured For:

KineticVet, PO Box 12388, Lexington, KY 40538

Made in USA

www.KineticVet.com

TAKE TIME        OBSERVE LABEL DIRECTIONS

SPL UNCLASSIFIED SECTION

Before using this drug, read package onsert for full prescribing information.

WITHDRAWAL PERIODS AND RESIDUE WARNINGS:

RESIDUE WARNING SECTION

Cattle: Milk taken during treatment and for 24 hours after the last treatment must not be used for human consumption.  Cattle must not be slaughtered for human consumption within 4 days following the last treatment with this drug product.  Not for use in beef calves less than 2 months of age, dairy calves, and veal calves.  A withdrawal period has not been established for this product in pre-ruminating calves.

ANIMAL SAFETY WARNINGS:

WARNINGS SECTION

Administration of tripelennamine hydrochloride may give rise to excitement, ataxia, and convulsions.

Central nervous system stimulation in the form of hyperexcitability, nervousness, and muscle tremors lasting up to 20 minutes have been noted in horses following administration.

Depression of the central nervous system and incoordination may occur when the drug is used at therapeutic dose levels.  Disturbances in gastrointestinal function may occur in some instances.

OTHER WARNINGS:

WARNINGS SECTION

Horses - Do not use in horses intended for human consumption.

USER SAFETY WARNINGS:

USER SAFETY WARNINGS SECTION

Not for use in humans.  Keep out of reach of children. To obtain a Safety Data Sheet, contact KineticVet at 1-877-786-9882 or www.KineticVet.com.

ACTIVE INGREDIENTS:

SPL UNCLASSIFIED SECTION

Each mL contains 20 mg of tripelennamine hydrochloride USP per mL of aqueous solution.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Sodium hydroxide may be added to adjust pH.

CONTACT INFORMATION:

SPL UNCLASSIFIED SECTION

Contact KineticVet at (877) 786-9882 or www.KineticVet.com.  To report suspected adverse drug experiences, contact KineticVet at (877) 786-9882.  For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

HOW SUPPLIED:

HOW SUPPLIED SECTION

100 mL, 250 mL and 500 mL multiple dose vials.

SPL PATIENT PACKAGE INSERT SECTION

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51031-025-25

RE-COVR™ (tripelennamine hydrochloride injection)

20 mg per mL

Antihistamine

Horses - For intramuscular injection only

Cattle - For intravenous or intramuscular injection

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

KINETICVET

Net Contents: 250 mL

Approved by FDA under NADA # 006-417

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2593950RE-COVR 20 MG/ML Injectable SolutionPSN2
2593945tripelennamine hydrochloride 20 MG/ML Injectable SolutionPSN2
2593950tripelennamine hydrochloride 20 MG/ML Injectable Solution [Re-Covr]SBD2
2593945tripelennamine hydrochloride 20 MG/ML Injectable SolutionSCD2
2593950Re-Covr 20 MG/ML Injectable SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51031-025-25RE-COVR250 mL in 1 BOTTLE, GLASSINJECTION2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51031-025RE-COVR (TRIPELENNAMINE HYDROCHLORIDE) INJECTION [KINETIC TECHNOLOGIES, LLC]21 package rows20220225_2010c3e9-a34e-421c-b436-821245aecb6e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51031-02551031-025-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIPELENNAMINE HYDROCHLORIDEFWV8GJ56ZNACTIM

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.