IVERHART MAX SOFT CHEW TOY (6-12 LBS)- ivermectin/pyrantel pamoate/praziquantel tablet, chewable IVERHART MAX SOFT CHEW SMALL (12.1-25 LBS)- ivermectin/pyrantel pamoate/praziquantel tablet, chewable IVERHART MAX SOFT CHEW MEDIUM (25.1-50 LBS)- ivermectin/pyrantel pamoate/praziquantel tablet, chewable IVERHART MAX SOFT CHEW LARGE (50.1-100 LBS)- ivermectin/pyrantel pamoate/praziquantel tablet, chewable

IVERHART MAX Soft Chew by

Drug Labeling and Warnings

IVERHART MAX Soft Chew by is a Animal medication manufactured, distributed, or labeled by Virbac AH, Inc, Virbac Bridgeton, Shandong Qilu King-Phar Pharmaceutical Co., Ltd., Cosma S.p.A, Cipla Limited Manufacturing Division, SOLARA ACTIVE PHARMA SCIENCES LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GENERAL PRECAUTIONS

For oral use in dogs only.

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

Description:

IVERHART MAX® Soft Chew is a combination of three anthelmintics (ivermectin/pyrantel pamoate/praziquantel). The soft chews are available in four sizes in color-coded packages for oral administration to dogs according to their weight (see Dosage and Administration).

Indications:

For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma
caninum, Uncinaria stenocephala, Ancylostoma braziliense), and tapeworms (Dipylidium caninum, Taenia pisiformis).

Dosage and Administration:

IVERHART MAX Soft Chew should be administered orally at monthly intervals and the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/ lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb), and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight, as follows: 

Dosing Schedule 

Dog Weight; Pounds	Soft Chew; per; Month	Soft Chew; Size	Ivermectin; Content	Pyrantel; Pamoate; Content	Praziquantel; Content
6.0 to 12	1	Toy	34 mcg	28.5 mg	28.5 mg
12.1 to 25	1	Small	68 mcg	57 mg	57 mg
25.1 to 50	1	Medium	136 mcg	114 mg	114 mg
50.1 to 100	1	Large	272 mcg	228 mg	228 mg

IVERHART MAX Soft Chew is recommended for dogs 8 weeks of age or older. For dogs over 100 lbs, use the appropriate combination of these soft chews. Remove only one dose at a time from the packaging. Return the remaining soft chew(s) to their box to protect from light. The soft chew can be offered to the dog by hand or added, intact, to a small amount of dog food. Care should be taken to ensure that the dog consumes the complete dose. The treated dog should be observed for a few minutes after administration to confirm that none of the dose has been lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended.

IVERHART MAX Soft Chew 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 dogs first exposure to mosquitoes. The final dose must be given within a month (30 days) after the dogs last exposure to mosquitoes. 

When replacing another heartworm preventative product in a heartworm disease prevention program, the first dose of IVERHART MAX Soft Chew must be given within a month (30 days) of the last dose of the former medication. A heartworm test should be performed prior to switching heartworm preventative products. 

If the interval between doses exceeds a month (30 days), the effectiveness of ivermectin can be reduced. Therefore, for optimal performance, the soft chew 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 IVERHART MAX Soft Chew and the recommended dosing regimen will minimize the opportunity for the development of adult heartworms.

Warnings:

For use in dogs only. Keep this and all drugs out of reach of children and pets. In safety studies with ivermectin/pyrantel pamoate/praziquantel tablets, testicular hypoplasia was observed in some dogs receiving 3 and 5 times the maximum recommended dose monthly for 6 months (see Animal Safety).

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.

Precautions:

Use with caution in sick, debilitated, or underweight animals and dogs weighing less than 10 lbs (see Animal Safety). The safe use of this drug has not been evaluated in pregnant or lactating bitches. 

All dogs should be tested for existing heartworm infection before starting treatment with IVERHART MAX Soft Chew, which is not effective against adult Dirofilaria immitis. Infected dogs should be treated to remove adult heartworms and microfilariae before initiating a heartworm
prevention program.

While some microfilariae may be killed by the ivermectin in IVERHART MAX Soft Chew at the recommended dose level, IVERHART MAX Soft Chew 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 alone after treatment of some dogs that have circulating microfilariae.

Adverse Reactions:

In a field study with IVERHART MAX Soft Chew, self-limiting adverse reactions, including vomiting, diarrhea, lethargy, difficulty swallowing, excessive salivation, increased water consumption, and coughing were reported. Self-limiting adverse reactions, including lethargy, limpness, salivation, shaking, diarrhea, decreased appetite, licking lips, and belching were reported between 20 minutes and 72 hours following treatment in a field study with ivermectin/pyrantel pamoate/praziquantel tablets.

In field studies with ivermectin/pyrantel pamoate tablets, vomiting or diarrhea within 24 hours of dosing was rarely observed (1.1% of administered doses). The following adverse reactions have been reported in dogs following the use of ivermectin products: depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions, and hypersalivation. 

To report suspected adverse events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact the FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Effectiveness:

Prevention of the tissue larval stage of heartworm (Dirofilaria immitis) and the elimination of the adult stage of hookworm (Ancylostoma caninum, Uncinaria stenocephala, Anyclostoma braziliense), roundworm (Toxocara canis, Toxascaris leonina), and tapeworm (Dipylidium
caninum, Taenia pisiformis) infections in dogs was demonstrated in well-controlled laboratory studies.

Palatability: In a field study of 132 dogs, IVERHART MAX Soft Chew was offered once monthly for 3 months. The dogs voluntarily consumed 86.3% of the doses from the owner’s hand or from a bowl within 5 minutes, 13.0% accepted the dose when it was offered in food or administered by placing onto the back of the dog’s tongue (pilling), and 0.7% of the doses were unable to be administered.

Animal Safety:

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 dose level of 6 mcg/kg) than dogs of other breeds. At elevated doses, sensitive dogs showed
more adverse reactions, which included mydriasis, depression, ataxia, tremors, drooling, paresis, recumbency, excitability, stupor, coma, and death. No signs of toxicity were seen at 10 times the recommended dose (27.2 mcg/lb) in sensitive Collies. Data from these studies support the safety of ivermectin products in dogs, including Collies, when used at the label recommended dose.

Because ivermectin and praziquantel are approximately 30% more bioavailable in the lVERHART MAX Soft Chew than in the ivermectin/pyrantel pamoate/praziquantel tablets used in the following target animal safety studies, the margin of safety is narrower than reported in these studies. The potential for adverse reactions may be greater in individual dogs administered IVERHART MAX Soft Chew than ivermectin/ pyrantel pamoate/praziquantel tablets.

In a target animal safety study using ivermectin/pyrantel pamoate/praziquantel tablets, doses were administered to 8-week-old Beagle puppies at one, three, and five times the maximum recommended dose of 12.5 mcg/kg ivermectin, 10.47 mg/kg pyrantel, and 10.47 mg/kg praziquantel. The dogs were treated every 30 days for 6 months. Vomiting within 6 hours of dosing and soft or watery feces within 24 hours of dosing were observed. Other observations during the study were: ano-genital swelling, lethargy, head movements, shallow, audible or difficult breathing, and salivation. One dog in the 5X group had tremors and decreased activity. All of these signs were transient. No treatment was required. Histopathology showed testicular hypoplasia in the 3X and 5X groups (see Warnings).

In a laboratory safety study using ivermectin/pyrantel pamoate/praziquantel tablets, 12‑week‑old Beagle puppies receiving 3 and 5 times the recommended dose once weekly for 13 weeks demonstrated a dose-related decrease in testicular maturation compared to controls. In this study, all treated puppies had significantly higher cholesterol levels compared to untreated controls.

In a reproductive safety study, adult males were treated at 37.5 mcg/kg ivermectin, 31.4 mg/ kg pyrantel, and 31.4 mg/kg praziquantel every 14 days during two full spermatogenic cycles (112 days). The quality of semen and reproductive health were not affected by treatment. Treatment‑related vomiting and soft feces were reported during this study.

In a study of the effectiveness of ivermectin/pyrantel pamoate/praziquantel tablets for the treatment of Toxocara canis, one 8.1 lb, 72-day-old puppy died 6 days after administration of the label dose. This puppy and many other puppies in the study had high worm burdens and were reported to have diarrhea, sometimes bloody, frequently before and after treatment. Dehydration and signs of anemia (pale mucous membranes) were the only abnormal gross necropsy finding observed. No definitive cause was determined. In a 90-day field study using ivermectin/pyrantel pamoate/praziquantel tablets, the most serious adverse reactions (lethargy, limpness, and salivation) were seen in dogs weighing less than 10 lbs (see Precautions).

Storage Information:

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F).

How Supplied:

IVERHART MAX Soft Chew is available in four dosage strengths (see Dosage and Administration) for dogs of different weights. Each strength comes in a package of 6 soft chews.

NADA 141-441, Approved by FDA.

Manufactured by: Virbac AH, Inc., Fort Worth, TX 76137 USA

Phone: 1-800-338-3659

© 2017 Virbac Corporation. IVERHART MAX is a registered trademark of Virbac Corporation.

302143-02

9/17

Principal Display Panel IVERHART MAX® Soft Chew 12.1-25 lbs (small)

FRONT PANEL:

IVERHART MAX® Soft Chew (milbemycin oxime/pyrantal pamoate/praziquantel)

Administer to dogs monthly for:

Prevention Against Heartworm Disease

Treatment and Control of Roundworm, Hookworm and Tapeworm Infections

WARNING: For use in dogs only. Keep this and all drugs out of reach of children and pets.

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
NADA 141-441, Approved by FDA.

NET CONTENTS: Contains 6 Soft Chews: Each Soft Chew contains 68 mcg ivermectin, 57 mg pyrantel as pamoate salt and 57 mg  praziquantel.

FOR DOGS 8 WEEKS OR OLDER

12.1-25 lbs

SIDE PANEL:

WARNINGS: Use product on or before its expiration date. Discard or return unused Soft Chews.

BACK PANEL:

IVERHART MAX® Soft Chew (milbemycin oxime/pyrantal pamoate/praziquantel)

See package insert for complete product safety information.
Each Soft Chew contains 68 mcg ivermectin, 57 mg pyrantel as pamoate salt and 57 mg praziquantel.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F).

Protect product from light.

For technical assistance or to report adverse drug reactions, please call 1-800-338-3659.
For complete product information, see package insert.

FOR DOGS 8 WEEKS OR OLDER

12.1-25 lbs

Manufactured by:
Virbac AH, Inc.
Fort Worth, TX 76137, USA
us.virbac.com
NADA 141-441, Approved by FDA.

Principal Display Panel IVERHART MAX® Soft Chew 25.1-50 lbs (medium)

FRONT PANEL:

IVERHART MAX® Soft Chew (milbemycin oxime/pyrantal pamoate/praziquantel)

Administer to dogs monthly for:

Prevention Against Heartworm Disease

Treatment and Control of Roundworm, Hookworm and Tapeworm Infections

WARNING: For use in dogs only. Keep this and all drugs out of reach of children and pets.

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
NADA 141-441, Approved by FDA.

NET CONTENTS: Contains 6 Soft Chews: Each Soft Chew contains 136 mcg ivermectin, 114 mg pyrantel as pamoate salt and 114 mg
praziquantel.

FOR DOGS 8 WEEKS OR OLDER

25.1-50 lbs

SIDE PANEL:

WARNINGS: Use product on or before its expiration date. Discard or return unused Soft Chews.

BACK PANEL:

IVERHART MAX® Soft Chew (milbemycin oxime/pyrantal pamoate/praziquantel)

See package insert for complete product safety information.
Each Soft Chew contains 136 mcg ivermectin, 114 mg pyrantel as pamoate salt and 114 mg praziquantel.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F).

Protect product from light.

For technical assistance or to report adverse drug reactions, please call 1-800-338-3659.
For complete product information, see package insert.

FOR DOGS 8 WEEKS OR OLDER

25.1-50 lbs

Manufactured by:
Virbac AH, Inc.
Fort Worth, TX 76137, USA
us.virbac.com
NADA 141-441, Approved by FDA.

Principal Display Panel IVERHART MAX® Soft Chew 50.1-100 lbs (large)

FRONT PANEL:

IVERHART MAX® Soft Chew (milbemycin oxime/pyrantal pamoate/praziquantel)

Administer to dogs monthly for:

Prevention Against Heartworm Disease

Treatment and Control of Roundworm, Hookworm and Tapeworm Infections

WARNING: For use in dogs only. Keep this and all drugs out of reach of children and pets.

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
NADA 141-441, Approved by FDA.

NET CONTENTS: Contains 6 Soft Chews: Each Soft Chew contains 272 mcg ivermectin, 228 mg pyrantel as pamoate salt and 228 mg praziquantel.

FOR DOGS 8 WEEKS OR OLDER

50.1-100 lbs

SIDE PANEL:

WARNINGS: Use product on or before its expiration date. Discard or return unused Soft Chews.

BACK PANEL:

IVERHART MAX® Soft Chew (milbemycin oxime/pyrantal pamoate/praziquantel)

See package insert for complete product safety information.
Each Soft Chew contains 272 mcg ivermectin, 228 mg pyrantel as pamoate salt and 228 mg praziquantel.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F).

Protect product from light.

For technical assistance or to report adverse drug reactions, please call 1-800-338-3659.
For complete product information, see package insert.

FOR DOGS 8 WEEKS OR OLDER

50.1-100 lbs

Manufactured by:
Virbac AH, Inc.
Fort Worth, TX 76137, USA
us.virbac.com
NADA 141-441, Approved by FDA.

Principal Display Panel IVERHART MAX® Soft Chew 6.0-12 lbs (toy)

FRONT PANEL:

IVERHART MAX® Soft Chew (milbemycin oxime/pyrantal pamoate/praziquantel)
Administer to dogs monthly for:
Prevention Against Heartworm Disease
Treatment and Control of Roundworm, Hookworm and Tapeworm Infections
WARNING: For use in dogs only. Keep this and all drugs out of reach of children and pets.
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
NADA 141-441, Approved by FDA.
NET CONTENTS: Contains 6 Soft Chews: Each Soft Chew contains 34 mcg ivermectin, 28.5 mg pyrantel as pamoate salt and 28.5 mg
FOR DOGS 8 WEEKS OR OLDER
6.0-12 lbs

SIDE PANEL:
WARNINGS: Use product on or before its expiration date. Discard or return unused Soft Chews.

BACK PANEL:
IVERHART MAX® Soft Chew (milbemycin oxime/pyrantal pamoate/praziquantel)
See package insert for complete product safety information.
Each Soft Chew contains 34 mcg ivermectin, 28.5 mg pyrantel as pamoate salt and 28.5 mg
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F).
Protect product from light.
For technical assistance or to report adverse drug reactions, please call 1-800-338-3659.
For complete product information, see package insert.
FOR DOGS 8 WEEKS OR OLDER
6.0-12 lbs

Manufactured by:
Virbac AH, Inc.
Fort Worth, TX 76137, USA
us.virbac.com
NADA 141-441, Approved by FDA.

INGREDIENTS AND APPEARANCE

IVERHART MAX SOFT CHEW  TOY (6-12 LBS)
ivermectin/pyrantel pamoate/praziquantel tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 51311-504
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)	IVERMECTIN	34 ug
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	28.5 mg
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	PRAZIQUANTEL	28.5 mg

Product Characteristics
Color	brown	Score	no score
Shape	RECTANGLE	Size	24mm
Flavor	MEAT ((bacon))	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-504-02	1 in 1 BOX
1		6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141441	03/01/2018

IVERHART MAX SOFT CHEW  SMALL (12.1-25 LBS)
ivermectin/pyrantel pamoate/praziquantel tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 51311-505
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)	IVERMECTIN	68 ug
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	57 mg
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	PRAZIQUANTEL	57 mg

Product Characteristics
Color	brown	Score	no score
Shape	RECTANGLE	Size	30mm
Flavor	MEAT ((bacon))	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-505-04	1 in 1 BOX
1		6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141441	03/01/2018

IVERHART MAX SOFT CHEW  MEDIUM (25.1-50 LBS)
ivermectin/pyrantel pamoate/praziquantel tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 51311-506
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)	IVERMECTIN	136 ug
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	114 mg
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	PRAZIQUANTEL	114 mg

Product Characteristics
Color	brown	Score	no score
Shape	RECTANGLE	Size	43mm
Flavor	MEAT ((bacon))	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-506-06	1 in 1 BOX
1		6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141441	02/01/2018

IVERHART MAX SOFT CHEW  LARGE (50.1-100 LBS)
ivermectin/pyrantel pamoate/praziquantel tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 51311-507
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)	IVERMECTIN	272 ug
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	228 mg
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	PRAZIQUANTEL	228 mg

Product Characteristics
Color	brown	Score	no score
Shape	RECTANGLE	Size	53mm
Flavor	MEAT ((bacon))	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-507-08	1 in 1 BOX
1		6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141441	01/02/2017

Labeler - Virbac AH, Inc (131568396)

Establishment
Name	Address	ID/FEI	Business Operations
Virbac Bridgeton		829166276	manufacture, analysis, label

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Qilu King-Phar Pharmaceutical Co., Ltd.		421524323	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Cosma S.p.A		428655732	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Cipla Limited Manufacturing Division		916940208	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
SOLARA ACTIVE PHARMA SCIENCES LIMITED		676159823	api manufacture