ADVANTUS SOFT CHEW- imidacloprid tablet, chewable

Advantus by

Drug Labeling and Warnings

Advantus by is a Animal medication manufactured, distributed, or labeled by Bayer HealthCare, LLC Animal Health Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

advantusTM is a favored soft chew for dogs and puppies 10 weeks of age and older and weighing 4 pounds or greater.

Active Ingredients:

advantus™ contains 7.5 mg or 37.5 mg of imidacloprid.

Use:

advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or greater.

Warnings:

Not for human use. Keep this and all drugs out of the reach of children and pets.

Side Effects:

Side effects seen with this drug include vomiting, decreased appetite, decreased energy, soft stools and difficulty walking.

Directions:

You should weigh your dog before giving this medication to make sure you are using the right size for your dog. Do not give to puppies younger than 10 weeks of age or to dogs weighing less than 4 pounds. Do not give more than one tablet a day.

Use the table to find the right dose for your dog:

Dosing Table

Body Weight	Dose	Soft Chew Strength
4-22 lbs	One soft chew	7.5 mg imidacloprid
23-110 lbs	One soft chew	37.5 mg imidacloprid

To give advantus™, place the soft chew directly in your dog’s mouth or allow your dog to take the soft chew from your hand. Watch closely to ensure your dog swallows the soft chew.

A single dose kills adult fleas on your dog. Because advantus™ does not have an effect on fleas in the environment, your dog may become re-infested with fleas. If your dog becomes reinfested, you can safely repeat treatment as often as once a day. Contact your veterinarian if you have any questions about flea infestations on your dog.

Treat all pets in your household with a flea protection product. advantus™ should only be given to dogs.

SPL UNCLASSIFIED SECTION

Questions/Comments? Call Bayer at 1-800-255-6826. To report side effects, call Bayer Veterinary Services at 1-800-422-9874. For additional information for reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Other Information:

• Contact your veterinarian if your dog ingests more than the recommended dose of advantus™.
• advantus™ has not been tested in pregnant or nursing dogs.
• advantus™ starts to kill fleas within 1 hour. A study demonstrated that advantus™ achieves greater than 96% effectiveness against adult fleas within 4 hours.
• advantus™ may be used together with other products, including heartworm preventatives, corticosteroids, antibiotics, vaccines, deworming medications and shampoos.
• advantus™ does not protect against ticks or mosquitoes.

Flea Infestations on Dogs:

Treatment of flea infestations is important to your dog’s health. Fleas in your dog’s environment can re-infest your dog. Therefore, you may need to treat with advantus™ more than one time. The following diagram illustrates the flea’s life cycle and where advantus™ works:

Fleas reproduce rapidly. A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and may grow into adults in only three weeks. Adult female fleas feed by ingesting blood from your dog and lay eggs that drop off from your dog’s coat. Within days, larvae hatch from these eggs and live undetected in your dog’s surroundings, such as in the carpet and bedding. Fleas can emerge to re-infest your pet, continuing the life cycle. When these new fleas are seen on your dog, treat with advantus™.

If you have any questions about flea treatment or medical problems associated with flea infestations, consult your veterinarian.

Storage Information:

Store at temperatures between 68° and 77°F (20°-25°C).

How Supplied:

advantus™ is available in two strengths: 7.5 mg or 37.5 mg imidacloprid. Both strengths are packaged in 7 count bottles containing 7 flavored soft chews or 30 count bottles containing 30 flavored soft chews.

NADA 141-435, Approved by FDA

Bayer HealthCare LLC, Animal Health Division, Shawnee Mission, KS 66201 USA

                                                                                                                       

©2016 Bayer                                                                                                                85694731 LV1702

Bayer (reg’d), the Bayer Cross (reg’d) and advantusTM are trademarks of Bayer.

Made in Spain.

Principal Display Panel – 7.5 mg carton label

ORAL FLEA TREATMENT FOR
DOGS 10 WEEKS OF AGE AND
OLDER, BETWEEN 4 TO 22 LBS

kills fleas

advantusTM

(imidacloprid) soft chew
7.5 mg

STARTS TO KILL FLEAS WITHIN 1 HOUR

KEEP OUT OF REACH OF CHILDREN

NADA 141-435
APPROVED BY FDA

7 SOFT CHEWS

Principal Display Panel – 7.5 mg unit label

ORAL FLEA TREATMENT FOR
DOGS 10 WEEKS OF AGE AND OLDER,
BETWEEN 4 TO 22 LBS

advantusTM

(imidacloprid) soft chew
7.5 mg

STARTS TO KILL FLEAS WITHIN 1 HOUR

KEEP OUT OF REACH OF CHILDREN

NADA 141-435
APPROVED BY FDA

7 SOFT CHEWS

ORAL FLEA TREATMENT FOR
DOGS 10 WEEKS OF AGE AND
OLDER, BETWEEN 4 TO 22 LBS

kills fleas

advantusTM

(imidacloprid) soft chew
7.5 mg

STARTS TO KILL FLEAS WITHIN 1 HOUR

KEEP OUT OF REACH OF CHILDREN

NADA 141-435
APPROVED BY FDA

30 SOFT CHEWS

Principal Display Panel – 37.5 mg carton label

ORAL FLEA TREATMENT FOR
DOGS 10 WEEKS OF AGE AND
OLDER, BETWEEN 23 TO 110 LBS

kills fleas

advantusTM

(imidacloprid) soft chew
37.5 mg

STARTS TO KILL FLEAS WITHIN 1 HOUR

KEEP OUT OF REACH OF CHILDREN

NADA 141-435
APPROVED BY FDA

7 SOFT CHEWS

Principal Display Panel – 37.5 mg unit label

ORAL FLEA TREATMENT FOR
DOGS 10 WEEKS OF AGE AND OLDER,
BETWEEN 23 TO 110 LBS

kills fleas

advantusTM

(imidacloprid) soft chew
37.5 mg

STARTS TO KILL FLEAS WITHIN 1 HOUR

KEEP OUT OF REACH OF CHILDREN

NADA 141-435, APPROVED BY FDA

7 SOFT CHEWS

ORAL FLEA TREATMENT FOR
DOGS 10 WEEKS OF AGE AND OLDER,
BETWEEN 23 TO 110 LBS

kills fleas

advantusTM

(imidacloprid) soft chew
37.5 mg

STARTS TO KILL FLEAS WITHIN 1 HOUR

KEEP OUT OF REACH OF CHILDREN

NADA 141-435
APPROVED BY FDA

30 SOFT CHEWS

INGREDIENTS AND APPEARANCE

ADVANTUS  SOFT CHEW
imidacloprid tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 0859-2404
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IMIDACLOPRID (UNII: 3BN7M937V8) (IMIDACLOPRID - UNII:3BN7M937V8)	IMIDACLOPRID	7.5 mg

Product Characteristics
Color	RED	Score	no score
Shape	TRAPEZOID	Size	14mm
Flavor	MEAT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0859-2404-02	1 in 1 CARTON
1	NDC: 0859-2404-01	7 in 1 BOTTLE
2	NDC: 0859-2404-03	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141435	01/01/2017

ADVANTUS  SOFT CHEW
imidacloprid tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 0859-2405
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IMIDACLOPRID (UNII: 3BN7M937V8) (IMIDACLOPRID - UNII:3BN7M937V8)	IMIDACLOPRID	37.5 mg

Product Characteristics
Color	BROWN	Score	no score
Shape	TRAPEZOID	Size	14mm
Flavor	MEAT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0859-2405-02	1 in 1 CARTON
1	NDC: 0859-2405-01	7 in 1 BOTTLE
2	NDC: 0859-2405-03	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141435	01/01/2017

Labeler - Bayer HealthCare, LLC Animal Health Division (152266193)