Animal NDC 58198-0017-2 Advantus
Imidacloprid

Animal Product Information

Field Name Field Value
Animal NDC Code 58198-0017-2
Proprietary Name Advantus What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Imidacloprid What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Elanco Us Inc.
Product Type Otc Animal Drug
Usage Information
    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: *If your dog becomes re-infested, you can safely repeat treatment as often as once a day. Dosing TableBodyWeightDose*Soft Chew Strength4-22 lbs One Soft Chew 7.5 mg imidacloprid 23-110lbs 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 re-infested, 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.
Active Ingredient(s)
  • Imidacloprid
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141435 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Advantus Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



advantus® is a flavored 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 reach of children.

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


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:

*If your dog becomes re-infested, you can safely repeat treatment as often as once a day.

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 re-infested, 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.


Questions/Comments?



For product questions or to report side effects, call Elanco at 1-800-255-6826. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae


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, de- worming 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.

Approved by FDA under NADA # 141-435

Elanco US Inc.

Shawnee, KS 66216 USA

87082652 LV2009

September, 2020

TAKE TIME

OBSERVE LABEL DIRECTIONS

Made in Spain.

advantus and Elanco are trademarks
of Elanco or its affiliates.

©2020 Elanco

Elanco


Principal Display Panel - 7.5 Mg 7 Tablet Carton Label



ORAL FLEA
TREATMENT FOR
DOGS 10 WEEKS
OF AGE AND
OLDER,
BETWEEN
4–22 lbs.

Elanco
advantus®

(imidacloprid) soft chew

7.5 mg

ORAL FLEA TREATMENT

Starts to kill fleas on dogs
within one hour

7
SOFT
CHEWS

Each soft chew contains
7.5 mg of imidacloprid.

Approved by FDA under NADA # 141-435

KEEP OUT OF REACH
OF CHILDREN


Principal Display Panel - 7.5 Mg 30 Tablet Bottle Label



Peel
Here

ORAL FLEA
TREATMENT FOR
DOGS 10 WEEKS
OF AGE AND
OLDER,
BETWEEN
4–22 lbs.

Elanco
advantus™

(imidacloprid) soft chew

7.5 mg

ORAL FLEA TREATMENT

Starts to kill fleas on dogs
within one hour

30
SOFT
CHEWS

Each soft chew contains 7.5 mg of imidacloprid.

Approved by FDA under NADA # 141-435

KEEP OUT OF REACH
OF CHILDREN


Principal Display Panel - 37.5 Mg 7 Tablet Carton Label



ORAL FLEA
TREATMENT FOR
DOGS 10 WEEKS
OF AGE AND
OLDER,
BETWEEN
23–110 lbs.

Elanco
advantus®

(imidacloprid) soft chew

37.5 mg

ORAL FLEA TREATMENT

Starts to kill fleas on dogs
within one hour

7
SOFT
CHEWS

Each soft chew contains
37.5 mg of imidacloprid.

Approved by FDA under NADA # 141-435

KEEP OUT OF REACH
OF CHILDREN


Principal Display Panel - 37.5 Mg 30 Tablet Bottle Label



Peel
Here

ORAL FLEA
TREATMENT FOR
DOGS 10 WEEKS
OF AGE AND
OLDER,
BETWEEN
23–110 lbs.

Elanco
advantus™

(imidacloprid) soft chew

37.5 mg

ORAL FLEA TREATMENT

Starts to kill fleas on dogs
within one hour

30
SOFT
CHEWS

Each soft chew contains 37.5 mg of imidacloprid.

Approved by FDA under NADA # 141-435

KEEP OUT OF REACH
OF CHILDREN


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.