SENTRY CAPGUARD- nitenpyram tablet 
Sergeant's Pet Care Products Inc.

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Sentry CapGuard

SENTRY®
CAPGUARD
(nitenpyram)

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

Active Ingredients

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

Warnings

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

Directions

CAPGUARD™ 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 CAPGUARD™ 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 CAPGUARD™ 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

CAPGUARD™ 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

Adverse Reactions

Pre-approval laboratory and clinical studies showed that CAPGUARD™ 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.

To report suspected adverse drug events, contact Sergeant’s Pet Care Products, Inc., at 1-855-451-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 Sergeant’s Pet Care Products, Inc. at 1-855-451-FAST (3278)

Other Information

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

CAPGUARD™ 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.

CAPGUARD™ Tablets kill adult fleas that cause flea allergy dermatitis (FAD).

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

Flea Infestations on Dogs and Cats

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.

CAPGUARD™ 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 CAPGUARD™ Tablets work:

Flea Life Cycle.

Life Cycle of the Flea

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 CAPGUARD™ 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.

Storage Conditions

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 1-855-451-FAST (3278)

Visit our web site at www.sentrypetcare.com

Manufactured For: Sergeant’s Pet Care Products, Inc., Omaha, NE 68138

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

P005419
RRRC

Principal Display Panel - 11.4 mg Carton Label

SENTRY®

CAPGUARD®

(NITENPYRAM)

11.4 mg

6 Tablets

(11.4 mg nitenpyram each)

For Dogs & Cats

2–25 lbs.

For treatment of FLEA infestations on dogs and cats.

FOR ORAL USE.

NADA #141-175

Approved by FDA

Principal Display Panel - 11.4 mg Carton Label

Principal Display Panel - 11.4 mg Carton Label

SENTRY®

CAPGUARD®

(NITENPYRAM)

11.4 mg

6 Tablets

(11.4 mg nitenpyram each)

For Dogs & Cats

2–25 lbs.

For treatment of FLEA infestations on dogs and cats.

FOR ORAL USE.

NADA #141-175

Approved by FDA

Principal Display Panel - 11.4 mg Carton Label

Principal Display Panel - 57 mg Carton Label

SENTRY®

CAPGUARD®

(NITENPYRAM)

57.0 mg

6 Tablets

(57.0 mg nitenpyram each)

For Dogs Over 25 lbs.

For treatment of FLEA infestations on dogs.

FOR ORAL USE.

NADA #141-175

Approved by FDA

Principal Display Panel - 57 mg Carton Label
SENTRY CAPGUARD 
nitenpyram tablet
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:21091-879
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nitenpyram (UNII: 3A837VZ81Y) (Nitenpyram - UNII:3A837VZ81Y) Nitenpyram11.4 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITE (to yellow) Scoreno score
ShapeROUND (biconvex beveled edges) Size6mm
FlavorImprint Code RB;CG
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21091-879-011 in 1 BOX, UNIT-DOSE
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14117504/15/201409/30/2018
SENTRY CAPGUARD 
nitenpyram tablet
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:21091-878
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nitenpyram (UNII: 3A837VZ81Y) (Nitenpyram - UNII:3A837VZ81Y) Nitenpyram57 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITE (to yellow) Scoreno score
ShapeROUND (biconvex beveled edges) Size11mm
FlavorImprint Code HIH;CG
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21091-878-011 in 1 BOX, UNIT-DOSE
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14117504/15/201409/30/2018
Labeler - Sergeant's Pet Care Products Inc. (876995171)

Revised: 12/2017
 
Sergeant's Pet Care Products Inc.