HEARTGARD

Manufacturer
Merial, Inc.
Effective date
2021-09-30
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:34:30

Label at a glance#

ProductHEARTGARD
Active ingredientivermectin
Label structure11 sections

Storage and handling

HEARTGARD Chewables for Cats are stable for 3 years when stored below 77°F (25°C) and protected from light. Store at controlled room temperature of 68°F-77°F (20°C-25°C). Excursions between 59°F-86°F (15°C-30°C) are permitted.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Chewables for Cats

Caution

SPL UNCLASSIFIED SECTION

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

INDICATION

VETERINARY INDICATIONS SECTION

For use in cats to prevent feline heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection, and for the removal and control of adult and immature hookworms (Ancylostoma tubaeforme and A. braziliense).

DOSAGE

DOSAGE & ADMINISTRATION SECTION

HEARTGARD for Cats should be administered orally at monthly intervals at the recommended minimum dose level of 24 mcg of ivermectin per kg (10.9 mcg/lb) of body weight. The recommended dosage schedule for prevention of feline heartworm disease and control of hookworm is as follows:

Cat Weight lbHEARTGARD for Cats Chewables per MonthIvermectin content
For cats over 15 lb, use the appropriate combination of chewables.
HEARTGARD for Cats is recommended for use in cats 6 weeks of age and older.

Up to 5 lb

1

55 mcg

5 to 15 lb

1

165 mcg

ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Remove only one chewable at a time from the foil-backed blister card. Return the card with the remaining chewables to its box to protect the product from light. HEARTGARD for Cats can be offered to the cat by hand or may be added to a small amount of cat food. If manual dosing is required, the chewable should be broken into pieces for administration. Food should be routinely available during the day of treatment administration. If cats are fasted, or if the chewable is not broken into pieces for manual dosing, then reduced absorption may result. A relationship between reduced absorption and reduced efficacy has not been established.

Care should be taken to see that the cat consumes the complete dose. 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 with a new chewable is recommended. Fragments of chewables have occasionally been observed in the feces of some cats; efficacy of the product was not adversely affected.

HEARTGARD for Cats should be given at monthly intervals when mosquitoes potentially carrying infective heartworm larvae are active. The initial dose must be given within a month (30 days) after the cat's first exposure to mosquitoes. The final dose must be given within a month (30 days) after the cat's last exposure to mosquitoes. For optimal performance, HEARTGARD for Cats must be given once a month on or about the same date. If treatment is delayed, whether by a few days or many, immediate treatment with HEARTGARD for Cats and resumption of the recommended dosing regimen will minimize the opportunity for development of adult heartworm.

It is recommended that cats should be tested for existing heartworm infection prior to starting treatment with HEARTGARD for Cats. Cats already infected with adult heartworms can be given HEARTGARD for Cats monthly to prevent further infections.

Monthly treatment with HEARTGARD® (ivermectin) for Cats also provides effective removal and control of adult and immature hookworms (A. tubaeforme and A. braziliense).

SAFETY

SPL UNCLASSIFIED SECTION

In the clinical studies involving more than 3000 doses of HEARTGARD for Cats, observations reported within 24 hours of treatment included vomition in ≤ 0.3% and diarrhea in ≤ 0.2% of the doses administered. There were no statistical differences between HEARTGARD for Cats and the product vehicle (control) for these observations.

A wide margin of safety was demonstrated in clinical trials at the recommended dose level in cats and kittens 6 weeks of age and older and in laboratory studies in cats with circulating microfilariae of D. immitis. A wide margin of safety has also been demonstrated at 3 times the recommended dose in pregnant or breeding queens and breeding toms. No adverse effects were observed in either male or female cats or their offspring in breeding studies. A 30-fold safety margin over the minimum recommended dosage was established in a single dose tolerance study. In growing kittens dosed monthly for 8 consecutive doses, one cat given 5 times the market dose vomited and a second cat in this group experienced diarrhea within 24 hours of the initial treatment. In clinical trials, many commonly used flea control products, anthelmintics, vaccines, antibiotics and steroid preparations were administered with HEARTGARD for Cats without incident.

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.

STABILITY

STORAGE AND HANDLING SECTION

HEARTGARD Chewables for Cats are stable for 3 years when stored below 77°F (25°C) and protected from light. Store at controlled room temperature of 68°F-77°F (20°C-25°C). Excursions between 59°F-86°F (15°C-30°C) are permitted.

HOW SUPPLIED

HOW SUPPLIED SECTION

HEARTGARD for Cats is available in two dosage strengths (see DOSAGE section) for cats of different weights. Each strength comes in a convenient carton of 6 chewables, packed 10 cartons per tray.

SPL UNCLASSIFIED SECTION

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

Marketed by
Merial, Inc.
3239 Satellite Blvd.
Duluth, GA 30096
Made in USA

Merial is the Animal Health Division of sanofi.

NADA 141-078, Approved by the FDA.

©2015 Merial, Inc. All Rights Reserved.

Rev. 05-2015

1050-2169-05

©HEARTGARD and the Cat & Hand logo are registered trademarks of Merial.

PRINCIPAL DISPLAY PANEL - 55 mcg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Heartgard®
(ivermectin)

Chewables
for Cats

Administer once a month to prevent
heartworm disease and to remove and
control infections of hookworms in cats.

For
CATS
UP TO 5 lbs

6 Chewables
Each chewable contains 55 mcg of 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 - 55 mcg Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 55 mcg Tablet Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 165 mcg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Heartgard®
(ivermectin)

Chewables
for Cats

Administer once a month to prevent
heartworm disease and to remove and
control infections of hookworms in cats.

For
CATS
5 TO 15 lbs

6 Chewables
Each chewable contains 165 mcg of 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 - 165 mcg Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 165 mcg Tablet Blister Pack Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ivermectinACTIVE INGREDIENT8883YP2R6D2
ivermectinACTIVE MOIETY8883YP2R6D2

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50604-404050604-4040-1, 50604-4040-3
50604-404150604-4041-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ivermectin8883YP2R6DACTIB
ivermectin8883YP2R6DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINYYBA Corp59ea9767-2e0b-ebc2-e063-6294a90ab9042026-08-25WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAzurity Pharmaceuticals, Inc.58c9cc4d-b1f3-1b6f-e063-6294a90ab5972026-08-11WarningsName fallback
generic name: IVERMECTIN
Head Lice Treatment Ivermectin Lotion118mLIVERMECTINYunqi Cosmetics (Shenzhen) Co., Ltd56a37d8f-c1b8-465a-e063-6394a90aa3342026-07-15WarningsName fallback
generic name: IVERMECTIN
SYNTHABIO IvermectinIVERMECTINShenzhen Xuyan Technology Co., Ltd.540d6a24-68bf-50c8-e063-6294a90aaa302026-06-22WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAmerisourceBergen4e924212-cd7b-ccd9-e063-6394a90afb952026-04-16WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAjanta Pharma USA Inc.1fb17bc2-9192-4a0b-a3ee-fda9db035daa2026-04-09Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINA-S Medication Solutions104a5045-94b1-4022-bc49-719521f30f0d2026-03-03Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINViona Pharmaceuticals Inc2de5ee45-0465-4996-ac00-5bdd352b4ed72026-02-27Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINZydus Lifesciences Limited6d626814-5288-441c-9508-f7f5130feceb2026-02-27Name fallback
generic name: IVERMECTIN
IvermectinIVERMECTINSun Pharmaceutical Industries, Inc.dd2c66e6-bd50-46df-a335-26215d02d13b2025-12-22WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINEdenbridge Pharmaceuticals LLC.847a1dd7-d65b-4a0e-a67d-d90392059dac2025-12-18Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINBryant Ranch Prepack1061e454-d1dc-4293-b18d-9c8717fbbb402025-10-23Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINCVS Pharmacy326e85c6-b95f-6aa8-e063-6294a90a49852025-06-20WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINActavis Pharma, Inc.de9253c3-7d66-47fe-8ad7-8c0d4ee8ebda2025-05-31Adverse reactionsName fallback
generic name: IVERMECTIN
RID One and DoneIVERMECTINOystershell Consumer Health, Inc.731a15f8-3578-4a95-b04c-aa6cf44a46652025-03-07WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAdvagen Pharma Ltde88adfbc-e375-4fea-827e-6ec51ed6fd0a2025-01-29Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINWALMART INC.1608ec4a-2af4-4a43-a83f-5b25937068d12025-01-09WarningsName fallback
generic name: IVERMECTIN
IVERMECTINIVERMECTINDR. REDDY'S LABORATORIES, INC.4cb062d7-0597-4e92-b2f6-7129a95e95002024-11-19Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
SOOLANTRAIVERMECTINGalderma Laboratories, L.P.b1d5b166-ab06-4ab5-b0c6-31126238118a2024-10-24Adverse reactionsName fallback
generic name: IVERMECTIN
STROMECTOLIVERMECTINMerck Sharp & Dohme LLC681888c9-af79-4b7d-ae80-c3f4f6f1effd2024-09-20Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN

Reported adverse events (FAERS/openFDA)#

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