Drontal Plus

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

None of the 103 dogs treated with Drontal® Plus Anthelmintic Tablets in the clinical field studies exhibited drug-related side effects. Of the 40 dogs treated with Drontal Plus Taste Tabs® Tablets in laboratory studies, two dogs exhibited vomiting, one puppy exhibited bloody/mucoid stool and one puppy exhibited watery/profuse stool.

For customer service or to obtain product information, including Material Safety Data Sheet, call 1-800-633-3796. For medical emergencies or to report adverse reactions, call 1-800-422-9874.

Controlled safety evaluations have been conducted in dogs with Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Anthelmintic Tablets. Dogs receiving up to 5 times the label dosage (35 mg praziquantel, 35 mg pyrantel pamoate and 179 mg febantel per kg of body weight) for 3 consecutive days (3 times the label duration) showed clinical signs of vomition and non-formed stools. One dog receiving a 3 times labeled dose had elevated SGPT, SGOT, CPK and GGT readings (outside of normal range) at 6 days post-treatment. No additional findings were noted in hematology/clinical chemistry parameters nor were there any treatment-related histological lesions. Vomition was the only side effect observed when dogs received a single treatment of 61 mg praziquantel, 61 mg pyrantel pamoate and 305 mg febantel/kg with one dog having an elevated SGPT reading (outside of normal range) at 24 hours post-treatment which had returned to normal by 7 days.

Drontal® Plus Taste Tabs® Tablets should be stored at or below 77 °F (25 °C).

Un-blistered whole or partial tablets should be stored in a tightly sealed container.

1 Andrews P. 1976. Pharmacokinetic Studies with DRONCIT® in Animals Using a Biological Assay. Veterinary Medical Review. 2:154-165.

2 Campbell WC. 1986. The Chemotherapy of Parasitic Infections. J. Parasit. 72(1):45-61.

3 Hildreth MB Johnson MD and Kazacos KR. 1991. A Zoonosis of Increasing Concern in the United States. Compendium for Cont. Ed. 13(5): 727-740.

4 PD Carney WP and Woods CE. 1970. Studies on Sylvatic Echinococcosis, Ill. Host Occurrence and Geographic Distribution of Echinococcus multilocularisin the North Central United States. J. Parasit. 56(6): 1141-1150.

5 Georgi JR and Georgi ME. 1990. Parasitology for Veterinarians. W.B. Saunders Co. 118-138.

6 Soulsby EJL. 1982. Helminths, Arthropods and Protozoa of Domesticated Animals. 7th Edition. Lea & Febiger. 118-138.

7 Craig PS and McPharson CNL. 1988. Sodium Hypochlorite as an Ovicide for Echinococcus. Ann Trop Med. and Parasit. 82(2): 211-213.

8 Freedom of Information Summary (FOI) NADA 133-953 Vercom Paste (febantel and praziquantel).

Bayer HealthCare LLC

Animal Health Division

Shawnee Mission, Kansas 66201 USA

NADA 141-007, Approved by FDA

January, 2006 ©2006 Bayer HealthCare LLC

R.0 Bayer, the Bayer Cross, Drontal, and Taste

12894 Tabs are registered trademarks of Bayer