Worm Protector 2X Canine Anthelmintic, 2 fl oz

A 2 fl oz pyrantel pamoate suspension labeled for removal of specified roundworms and hookworms in dogs and puppies. The FDA label gives dose and follow-up instructions.

A measured liquid dose for dogs

ProLabs Worm Protector 2X is an oral pyrantel pamoate suspension for dogs and puppies. The current FDA label identifies the 2 fl oz bottle as 60 mL and lists 4.54 mg of pyrantel base, supplied as pyrantel pamoate, in each milliliter. This version is intended as a single treatment for removal of the large roundworms Toxocara canis and Toxascaris leonina and the hookworms Ancylostoma caninum and Uncinaria stenocephala. The label also gives directions for preventing Toxocara canis reinfestation in puppies, adult dogs, and lactating females after whelping. A product name that says “2X” does not mean the keeper should double the dose. The label's measured amount is one teaspoon, or 5 mL, for every 10 lb of body weight. Shake the bottle well before use and measure the dose carefully. Food does not need to be withheld before or after treatment. If a dog refuses the dose, the label permits mixing it with a small quantity of dog food. For puppies, the label recommends treatment at 2, 3, 4, 6, 8, and 10 weeks of age. It says lactating bitches may be treated 2 to 3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent roundworm reinfestation. For dogs under constant exposure to worm infestation, the label recommends a follow-up fecal exam 2 to 4 weeks after treatment. That follow-up can help determine whether treatment worked and whether additional veterinary assessment is needed. The FDA lists this product as an over-the-counter animal drug approved under ANADA 200-007. It is for dogs, not cats or people. Keep it in a secure place out of reach of children, dogs, cats, and other animals so a pet cannot accidentally consume more than the measured amount. Store below 86°F (30°C). The 2 oz package is one 60 mL bottle, with a separate UPC from the 8 oz version. Check the bottle's current label before use, especially when treating very young puppies, a pregnant or nursing dog, or an animal with an existing health problem.

FDA label and product identity

Active ingredient: pyrantel pamoate suspension delivering 4.54 mg pyrantel base per mL. Oral canine anthelmintic. Retail unit: one 2 fl oz (60 mL) bottle, manufacturer item 1792, UPC 357561017924; NDC 23243-1450-2. OTC animal drug approved under ANADA 200-007. The distinct 8 fl oz bottle is 236 mL and has a different UPC.

Directions for use

Shake well before using. Administer 1 teaspoon (5 mL) for each 10 lb of body weight. Food does not need to be withheld before or after treatment. If the dog is reluctant to take the dose, mix it in a small quantity of dog food. For maximum control and prevention of Toxocara canis reinfestation, the label recommends treating puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Treat lactating bitches 2 to 3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent reinfestation. Dogs under conditions of constant exposure to worm infestation should have a follow-up fecal exam within 2 to 4 weeks after treatment.

Cautions

NOT FOR USE IN HUMANS.

PRECAUTIONS: THIS PRODUCT IS A SUSPENSION AND AS SUCH WILL SEPARATE. TO ENSURE UNIFORM RESUSPENSION AND TO ACHIEVE PROPER DOSAGE, IT IS EXTREMELY IMPORTANT THAT THE PRODUCT BE SHAKEN THOROUGHLY BEFORE EVERY USE.

KEEP OUT OF REACH OF CHILDREN.

Keep WORM PROTECTOR 2X in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

RECOMMENDED STORAGE: STORE BELOW 86°F (30°C).

Contact Information: To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.