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Quick Tabs

Meridian Animal Health
Novartis Animal Health US, Inc.

Quick Tabs




FULL PRESCRIBING INFORMATION

Quick Tabs
( nitenpyram )

Quick Tabs is an oral tablet for dogs, puppies, cats and kittens 2 pounds of body weight   or greater and 4 weeks of age and older.

Quick Tabs Tablets contain 11.4 or 57.0 mg of nitenpyram, which belongs to the chemical class of neonicotinoids. Nitenpyram kills adult fleas.

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

Quick Tabs Tablets kill adult fleas and are indicated for the treatment of flea infestations on dogs, puppies, cats and kittens 2 pounds of body weight or greater and 4 weeks of age and older.

A single dose of Quick Tabs should kill the adult fleas on your pet. If your pet gets re-infested with fleas, you can safely give another dose as often as once per day.

To give Quick Tabs Tablets, place the pill directly in your pet’s mouth or hide it in food. If you hide the pill in food, watch closely to make sure your pet swallows the pill. If you are not sure that your pet swallowed the pill, it is safe to give a second pill.

Treat all infested pets in the household. Fleas can reproduce on untreated pets and allow infestations to persist.

Dosage

Quick Tabs Tablets should be administered according to the following schedule. Weigh   your pet prior to administration to ensure proper dosage. Do not administer   to pets under 2 pounds.

Recommended Dosage Schedule
Species Body Weight Dose Nitenpyram Per Tablet
Dog or Cat 2-25 lbs. One tablet 11.4 mg
Dog 25.1-125 lbs. One tablet 57.0 mg

Pre-approval laboratory and clinical studies showed that Quick Tabs Tablets are safe for use in dogs and cats, puppies and kittens 2 pounds of body weight or greater and 4 weeks of age and older. (See Post-Approval Experience section ).

The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are listed in decreasing order of reporting frequency.

CATS: hyperactivity, panting, lethargy, itching, vocalization, vomiting, fever, decreased appetite, nervousness, diarrhea, difficulty breathing, salivation, incoordination, seizures, pupil dilation, increased heart rate, and trembling.

DOGS: lethargy/depression, vomiting, itching, decreased appetite, diarrhea, hyperactivity, incoordination, trembling, seizures, panting, allergic reactions including hives, vocalization, salivation, fever, and nervousness.

The frequency of serious signs, including neurologic signs and death, was greater in   animals under 2 pounds of body weight, less than 8 weeks of age, and/or reported to   be in poor body condition. In some instances, birth defects and fetal/neonatal loss   were reported after treatment of pregnant and/or lactating animals.

To report suspected adverse drug events, contact Meridian Animal Health, at 1-855-560-FAST (3278) or the FDA at 1-800-FDA-VETS or: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

For a complete listing of adverse reactions for nitenpyram reported to the CVM see:

http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055394.htm

For technical assistance call Meridian Animal Health at 1-855-560-FAST (3278)

Quick Tabs Tablets begin working within 30 minutes. In studies, Quick Tabs achieved greater than 90% effectiveness against adult fleas on dogs within 4 hours and cats within 6 hours.

Quick Tabs Tablets are safe for pregnant or nursing dogs and cats (See Post-Approval Experience section).

When using this product, you may notice that your dog or cat will start scratching itself as fleas begin to die. The scratching behavior is temporary and is a reaction to the fleas, not the drug. In cats and dogs, this may present as transient signs of hyperactivity, panting, vocalization and excessive grooming/licking.

Quick Tabs Tablets kill adult fleas that cause flea allergy dermatitis (FAD).

Quick Tabs Tablets may be used together with other products, including heartworm preventives, corticosteroids, antibiotics, vaccines, de-worming medications, shampoos and other flea products.

In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in your pet such as flea allergy dermatitis (FAD) in the dog and miliary dermatitis in the cat. Also, fleas transmit other parasites, including tapeworms. The control of flea infestations is important to your pet’s health and also reduces the problems associated with these parasites.

Quick Tabs Tablets do not have an effect on fleas in the pet’s environment. You may need to treat more than one time because immature fleas in and around the home will continue to develop into adults that can reinfest your pet.

The following diagram illustrates the flea’s life cycle and where Quick Tabs Tablets work:

Quick Tabs

Fleas can be a problem because they reproduce so rapidly. A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from your pet and subsequently lay eggs, which drop off your pet’s coat. Within days, larvae hatch from the eggs and live undetected in your pet’s surroundings, such as the carpet, bedding and other protected areas. Flea larvae spin a cocoon, and, when appropriately stimulated, a young adult flea emerges and jumps onto your pet to continue the life cycle. When these new fleas are seen on your pet, treat with Quick Tabs Tablets.

After reading this insert, if you have any questions about flea control or medical problems associated with flea infestations, consult your veterinarian, who is your pet’s health care expert.

Store at controlled room temperature, between 59° and 77°F (15°-25°C).

For questions, comments, technical assistance or to report a suspected adverse event

please call 1-855-560-FAST (3278)

Manufactured For: Meridian Animal Health, Omaha, NE 68138

NADA #141-175, Approved by FDA.
NAH/SER-MD.11.4-57CF/PI/1

P068189
RRRC

Dog&CatMD
QuickTabs
(
n itenpyram )
11.4 mg

6 tablets

For Dogs & Cats

2-25 lbs.

Quick Tabs

DogMD
QuickTabs
(
nitenpyram )
57.0 mg

6 tablets

For Dogs

Over 25 lbs.

Quick Tabs

Quick Tabs

nitenpyram TABLET

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:48688-876
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
NITENPYRAM NITENPYRAM 11.4 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (to light yellow) 6 mm RB;CG ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:48688-876-01 1 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141175 2014-04-15


Quick Tabs

nitenpyram TABLET

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:48688-873
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
NITENPYRAM NITENPYRAM 57.0 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (to light yellow) 11 mm HIH;CG ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:48688-873-01 1 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141175 2014-04-15


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