Capstar: Product Information (Page 2 of 2)

Principal Display Panel — 11.4 mg Carton Label

Capstar™

(nitenpyram)

11.4 mg

60 Tablets

(11.4 mg nitenpyram each)

For Dogs and Cats

2–25 lbs.

For treatment of flea infestations on dogs and cats.

For Oral Use.

NADA #141-175

Approved by FDA

Product # 604152

Elanco

Principal Display Panel -- 11.4 mg Carton Label
(click image for full-size original)

Principal Display Panel — 11.4 mg Dog Carton Label

CAPSTAR™

(nitenpyram)

11.4 mg

Treatment of flea
infestations on dogs

For oral use

Beings workingwithin 30 minutes

For dogs 2-25 lbs | 6 tablets (11.4 mg each)

Keep this and all drugs out of reach of children

[NADA #141-174 Approved by FDA]

Elanco™

Principal Display Panel -- 11.4 mg Dog Carton Label
(click image for full-size original)

Principal Display Panel — 11.4 mg Cat Box Label

CAPSTAR™

(nitenpyram)

11.4 mg

Treatment of flea
infestations on cats

For oral use

Begins workingwithin 30 minutes

For cats 2-25 lbs | 60 tablets

[NADA #141-175 Approved by FDA]

Elanco™

Principal Display Panel -- 11.4 mg Cat Box Label
(click image for full-size original)

Principal Display Panel — 11.4 mg Cat Carton Label

CAPSTAR™

(nitenpyram)

11.4 mg

Treatment of flea
infestations on cats

For oral use

Beings workingwithin 30 minutes

For cats 2-25 lbs | 6 tablets (11.4 mg each)

Keep this and all drugs out of reach of children

[NADA #141-174 Approved by FDA]

Elanco™

Principal Display Panel -- 11.4 mg Cat Carton Label
(click image for full-size original)

Principal Display Panel — 57.0 mg Dog Box Label

CAPSTAR™

(nitenpyram)

57.0 mg

Treatment of flea
infestations on dogs

For oral use

Begins workingwithin 30 minutes

for dogs over 25lbs | 60 tablets

[NADA #141-175 Approved by FDA]

Elanco™

Principal Display Panel -- 57.0 mg Dog Box Label
(click image for full-size original)

Principal Display Panel — 57.0 mg Dog Box Label

CAPSTAR™

(nitenpyram)

57.0 mg

Treatment of
flea infestations
on dogs

For oral use

60 tablets

(57.0 mg nitenpyram each)

Begins
working within30 minutes

Principal Display Panel -- 57.0 mg Dog Box Label
(click image for full-size original)

Principal Display Panel — 57.0 mg Dog Carton Label

CAPSTAR™

(nitenpyram)

57.0 mg

Treatment of flea
infestations on cats

For oral use

Beings workingwithin 30 minutes

For dogs over 25 lbs | 6 tablets (57.0 mg each)

Keep this and all drugs out of reach of children

[NADA #141-174 Approved by FDA]

Elanco™

Principal Display Panel -- 57.0 mg Dog Carton Label
(click image for full-size original)
CAPSTAR nitenpyram tablet
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-4920
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nitenpyram (Nitenpyram) Nitenpyram 11.4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (to yellow) Score no score
Shape ROUND (biconvex beveled edges) Size 6mm
Flavor Imprint Code RB;CG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-4920-1 1 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 6 TABLET in 1 BLISTER PACK This package is contained within the BOX (58198-4920-1)
2 NDC:58198-4920-5 10 BOX in 1 CARTON contains a BOX
2 6 TABLET in 1 BOX This package is contained within the CARTON (58198-4920-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141175 10/20/2000
CAPSTAR nitenpyram tablet
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-4925
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nitenpyram (Nitenpyram) Nitenpyram 57 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (to yellow) Score no score
Shape ROUND (biconvex beveled edges) Size 11mm
Flavor Imprint Code HIH;CG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-4925-1 1 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 6 TABLET in 1 BLISTER PACK This package is contained within the BOX (58198-4925-1)
2 NDC:58198-4925-5 10 BOX in 1 CARTON contains a BOX
2 6 TABLET in 1 BOX This package is contained within the CARTON (58198-4925-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141175 10/20/2000
Labeler — Elanco US Inc. (966985624)
Registrant — Sergeants Pet Care Products LLC dba PetIQ (876995171)
Establishment
Name Address ID/FEI Operations
Elanco France SAS 736833104 ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 07/2021 Elanco US Inc.

Page 2 of 2 1 2

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