FELIX PHARMACEUTICALS PRIVATE LIMITED

Flea-Lix Nitenpyram Nitenpyram Nitenpyram ANHYDROUS LACTOSE STARCH, CORN MAGNESIUM STEARATE off white to pale yellow F25;I1 Flea-Lix Nitenpyram Nitenpyram Nitenpyram ANHYDROUS LACTOSE STARCH, CORN MAGNESIUM STEARATE off white to pale yellow F25;I2

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

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




Flea-Lix kills adult fleas and is 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 Flea-Lix 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 Flea-Lix 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.

Flea-Lix 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	2-25lbs.	One Tablet	11.4 mg
Dog	25.1-125lbs.	One Tablet	57.0 mg

Pre-approval laboratory and clinical studies showed that nitenpyram 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).  
Post-Approval Experience (Rev. 2011):
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.  


Contact Felix Pharmaceuticals Private Limited at 1-833-571-1525 or www.felixvet.com. To report suspected adverse drug experiences, contact Felix Pharmaceuticals Private Limited at 1-833-571-1525. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

To obtain a Safety Data Sheet(s), contact Felix Pharmaceuticals Private Limited at 1-833-571-1525.

Flea-Lix begins working within 30 minutes. In studies, nitenpyram achieved greater than 90% effectiveness against adult fleas on dogs within 4 hours and cats within 6 hours.

Flea-Lix is 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. Flea-Lix kills adult fleas that cause flea allergy dermatitis (FAD). Flea-Lix 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.

Flea-Lix does 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 Flea-Lix work:



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 Flea-Lix.
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.

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Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Questions? Comments? Please Call 1-833-571-1525

For technical assistance or to report a suspected adverse experiences please call 1-833-571-1525 Approved by FDA under ANADA # 200-858

Distributed by:
Felixvet Inc.,
1300 NW Briarcliff Parkway,
Suite 100, Kansas City, Missouri 64150 Manufactured in India
Neutral Code No. MP/DRUGS/25/90/2020
Rev. July 2026


Blister Foil 11.4 mg
 
foil foil1

Blister Foil  57.0 mg foill foil2

NDC: 86101-123-08 FOR DOGS
2-25 LBS
6 tablets | 11.4 mg Flea-Lix™
(nitenpyram tablets) Approved by FDA under ANADA # 200-858
dog

NDC: 86101-123-06 FOR CATS
2-25 LBS
6 tablets | 11.4 mg Flea-Lix™
(nitenpyram tablets) Approved by FDA under ANADA # 200-858 cat

NDC: 86101-124-06 FOR DOGS
OVER 25 LBS
6 tablets | 57.0 mg Flea-Lix™
(nitenpyram tablets) Approved by FDA under ANADA # 200-858
57

NDC: 86101-123-09 FOR DOGS  2-25 lbs | 60 tablets Flea-Lix™
(nitenpyram tablets) 11.4 mg Contains 10 6-count cartons Approved by FDA under ANADA # 200-858 dogg

NDC: 86101-123-10 FOR CATS  2-25 lbs | 60 tablets Flea-Lix
(nitenpyram tablets) 11.4 mg™ Contains 10 6-count cartons Approved by FDA under ANADA # 200-858 catt

NDC: 86101-124-07 FOR DOGS  Over 25 lbs | 60 tablets Flea-Lix™ (nitenpyram tablets) 57.0 mg Contains 10 6-count cartons Approved by FDA under ANADA # 200-858
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