SENTRY CAPGUARD nitenpyram tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAPGUARD™ Tablets contain 11.4 or 57.0 mg of nitenpyram, which belongs to thechemical class of neonicotinoids. Nitenpyram kills adult fleas.
Available from:
Sergeant's Pet Care Products Inc.
Prescription type:
OTC
Authorization status:
New Animal Drug Application

SENTRY CAPGUARD- nitenpyram tablet

Sergeant's Pet Care Products Inc.

----------

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.

Dos age

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

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:

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

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 - 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

®

SENTRY CAPGUARD

nitenpyram tablet

Product Information

Product T ype

OTC ANIMAL DRUG

Ite m Code (Source )

NDC:210 9 1-8 79

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Nitenpyra m (UNII: 3A8 37VZ8 1Y) (Nitenpyram - UNII:3A8 37VZ8 1Y)

Nite npyra m

11.4 mg

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Product Characteristics

Color

WHITE (to yello w)

S core

no sco re

S hap e

ROUND (bico nvex beveled edges)

S iz e

6 mm

Flavor

Imprint Code

RB;CG

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:210 9 1-8 79 -0 1

1 in 1 BOX, UNIT-DOSE

1

6 in 1 BLISTER PACK

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NADA

NADA141175

0 4/15/20 14

SENTRY CAPGUARD

nitenpyram tablet

Product Information

Product T ype

OTC ANIMAL DRUG

Ite m Code (Source )

NDC:210 9 1-8 78

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Nitenpyra m (UNII: 3A8 37VZ8 1Y) (Nitenpyram - UNII:3A8 37VZ8 1Y)

Nite npyra m

57 mg

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Product Characteristics

Color

WHITE (to yello w)

S core

no sco re

S hap e

ROUND (bico nvex beveled edges)

S iz e

11mm

Flavor

Imprint Code

HIH;CG

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:210 9 1-8 78 -0 1

1 in 1 BOX, UNIT-DOSE

1

6 in 1 BLISTER PACK

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NADA

NADA141175

0 4/15/20 14

Labeler -

Sergeant's Pet Care Products Inc. (876995171)

Registrant -

Elanco US Inc. (966985624)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Elanco France SAS

736 8 3310 4

ANALYSIS, LABEL, MANUFACTURE, PACK

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sergeant's Pet Care Pro ducts Inc.

8 76 9 9 5171

RELABEL

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sergeant's Pet Care Products Inc.

DOTTIKON EXCLUSIVE SYNTHESIS AG

48 0 0 0 0 413

API MANUFACTURE

Revised: 12/2017

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