Label: HEARTGARD FOR DOGS- ivermectin tablet 

  • NDC Code(s): 50604-4023-1, 50604-4024-1, 50604-4025-1
  • Packager: Merial Limited
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated 03/14

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

  • SPL UNCLASSIFIED SECTION

    NADA 138-412, Approved by the FDA

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  • WARNINGS

    Caution: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

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  • VETERINARY INDICATIONS

    INDICATION: For use in dogs to prevent canine heartworm disease.

    HEARTGARD® prevents heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection.

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  • DOSAGE & ADMINISTRATION

    DOSAGE: HEARTGARD Tablets should be administered orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb) of body weight. (See ADMINISTRATION). The recommended dosage schedule for prevention of canine heartworm disease is as follows:

      Dog Weight Tablets Per Month Ivermectin Per Tablet Color on Carton
    Give dogs over 100 lb the appropriate combination of tablets.
    HEARTGARD is recommended for use in dogs 6 weeks of age and older.
    Up to 25 lb 1   68 mcg Blue
    26 to 50 lb 1 136 mcg Green
    51 to 100 lb 1 272 mcg Brown

    ADMINISTRATION: The HEARTGARD tablet should be given so that dogs swallow the whole tablet. (The tablet may be wrapped in food to encourage consumption.) Care should be taken to see that the dog consumes the complete dose, and treated animals should be observed for a few minutes after administration to ensure that part of the dose is not lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended. HEARTGARD Tablets should be given at monthly intervals during the period of the year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active. The initial dose must be given within a month (30 days) after the first exposure to mosquitoes. The final dose must be given within a month (30 days) after the last exposure to mosquitoes.

    When replacing another heartworm preventive in a heartworm disease preventive program, the first dose of HEARTGARD must be given within a month (30 days) after the last dose of the former medication.

    If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be reduced. For optimal performance, the tablet must be given once a month on or about the same day of the month. If treatment is delayed, whether by a few days or many, immediate treatment with HEARTGARD and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms.

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  • SPL UNCLASSIFIED SECTION

    EFFICACY: HEARTGARD Tablets, given orally using the recommended dose and regimen, are effective against the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection and, as a result, prevent the development of the adult stage.

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  • PRECAUTIONS

    PRECAUTIONS: All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD® (ivermectin) Tablets, which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae prior to initiating a program with HEARTGARD.

    While some microfilariae may be killed by the ivermectin in HEARTGARD at the recommended dose level, HEARTGARD is not effective for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to dead or dying microfilariae and particularly involving a transient diarrhea, has been observed in clinical trials with ivermectin after the treatment of some dogs that have circulating microfilariae.

    Keep this and all drugs out of the reach of children. In case of ingestion by humans, clients should be advised to contact a physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of ingestion by humans.

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  • ADVERSE REACTIONS

    ADVERSE REACTIONS: The following adverse reactions have been reported following the use of HEARTGARD: Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation.

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  • SPL UNCLASSIFIED SECTION

    SAFETY: HEARTGARD has shown a wide margin of safety at the recommended dose level in dogs (See PRECAUTIONS for exceptions) including pregnant or breeding bitches, stud dogs, and puppies aged 6 or more weeks. In clinical trials, many commonly used flea collars, dips, shampoos, anthelmintics, antibiotics, vaccines, and steroid preparations have been administered with HEARTGARD in a heartworm disease preventive program.

    Studies with ivermectin indicate that certain dogs of the Collie breed are more sensitive to the effects of ivermectin administered at elevated dose levels (more than 16 times the target use level) than dogs of other breeds. At elevated doses, sensitive dogs showed adverse reactions which included mydriasis, depression, ataxia, tremors, drooling, paresis, recumbency, excitability, stupor, coma and death. HEARTGARD demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in sensitive Collies. Results of these trials support the safety of HEARTGARD products in dogs, including Collies, when used as recommended.

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  • HOW SUPPLIED

    HOW SUPPLIED: HEARTGARD is available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in a convenient carton of 6 tablets, packed 10 cartons per tray.

    Store at controlled room temperature 68° - 77°F (20° - 25°C).

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  • SPL UNCLASSIFIED SECTION

    For customer assistance, please contact Merial at 1-888-637-4251.

    Marketed by
    Merial Limited
    Duluth, GA 30096-4640

    ©2012 Merial. All rights reserved.

    Made in U.S.A.

    Rev. 01-2012
    1050-4383-00

    ®HEARTGARD and the Dog & Hand logo are registered trademarks of Merial.

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  • PRINCIPAL DISPLAY PANEL - 68 mcg Tablet Carton

    Heartgard®
    (ivermectin)

    Treat once a month to prevent
    heartworm disease in dogs.

    For
    DOGS
    UP TO 25 lbs

    6 Tablets
    Each tablet contains 68 mcg ivermectin.

    Keep this and all drugs out
    of the reach of children.

    Caution: Federal (U.S.A.) law restricts
    this drug to use by or on the order of
    a licensed veterinarian.

    MERIAL

    PRINCIPAL DISPLAY PANEL - 68 mcg Tablet Carton
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  • PRINCIPAL DISPLAY PANEL - 136 mcg Tablet Carton

    Heartgard®
    (ivermectin)

    Treat once a month to prevent
    heartworm disease in dogs.

    For
    DOGS
    26-50 lbs

    6 Tablets
    Each tablet contains 136 mcg ivermectin.

    Keep this and all drugs out
    of the reach of children.

    Caution: Federal (U.S.A.) law restricts
    this drug to use by or on the order of
    a licensed veterinarian.

    MERIAL

    PRINCIPAL DISPLAY PANEL - 136 mcg Tablet Carton
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  • PRINCIPAL DISPLAY PANEL - 272 mcg Tablet Carton

    Heartgard®
    (ivermectin)

    Treat once a month to prevent
    heartworm disease in dogs.

    For
    DOGS
    51-100 lbs

    6 Tablets
    Each tablet contains 272 mcg ivermectin.

    Keep this and all drugs out
    of the reach of children.

    Caution: Federal (U.S.A.) law restricts
    this drug to use by or on the order of
    a licensed veterinarian.

    MERIAL

    PRINCIPAL DISPLAY PANEL - 272 mcg Tablet Carton
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  • INGREDIENTS AND APPEARANCE
    HEARTGARD FOR DOGS 
    ivermectin tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50604-4023
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ivermectin (ivermectin) ivermectin 68 ug
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code 68;DogandHandLogo
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50604-4023-1 1 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA138412 04/01/2014
    HEARTGARD FOR DOGS 
    ivermectin tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50604-4024
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ivermectin (ivermectin) ivermectin 136 ug
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 136;DogandHandLogo
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50604-4024-1 1 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA138412 04/01/2014
    HEARTGARD FOR DOGS 
    ivermectin tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50604-4025
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ivermectin (ivermectin) ivermectin 272 ug
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 14mm
    Flavor Imprint Code 272;DogandHandLogo
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50604-4025-1 1 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA138412 04/01/2014
    Labeler - Merial Limited (034393582)
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