DIPHENHYDRAMINE HCL- antihistamine tablet

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Animal medication manufactured, distributed, or labeled by Sergeant's Pet Care Products Inc., L. Perrigo Company, Kongo Chemical Co., Ltd., Wanbury Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

FOR USE IN DOGS ONLY

Provides temporarily relief from:

Sensitive itching skin
Insect bites and stings
Travel anxiety

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

PURPOSE

Purpose Antihistamine

INDICATIONS & USAGE

Uses Temporarily relieves:

■ sensitive itching skin ■ insect bites and stings ■ travel anxiety

PRECAUTIONS

Caution
Ask a veterinarian before use if your dog is taking sedatives, trouble urinating, is or may be pregnant, is lactating, has weakness, vomiting or not eating

WARNINGS

Warnings
In case of accidental overdose of dog, contact a veterinarian or veterinary emergency clinic.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets.

INSTRUCTIONS FOR USE

Directions
■ Dogs weighing less than 14 pounds – ask a veterinarian
■ Dogs weighing 14 to 30 pounds - 1 tablet twice per day
■ Dogs weighing over 30 pounds - 2 tablets twice per day
■ The tablet can be given directly or hidden in a snack

OTHER SAFETY INFORMATION

Other information
■ consult a veterinarian if worse or no improvement of condition within 24 hours
■ store at 20 - 25°C (68-77°F) ■ protect from moisture

INACTIVE INGREDIENT

Inactive ingredients carnauba wax, crospovidone, D&C red no 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

QUESTIONS

Questions? Comments? 1-888-908-8425

OTHER SAFETY INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
antihistamine tablet

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 21091-693
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (UNII: 2S7830E561)
SOLVENT RED 27 (UNII: G7S71FND9B)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	L479
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21091-693-01	1 in 1 CARTON
1	NDC: 21091-693-02	100 in 1 BOTTLE, PLASTIC; Number of Units = 1

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/03/2018

Labeler - Sergeant's Pet Care Products Inc. (876995171)

Establishment
Name	Address	ID/FEI	Business Operations
L. Perrigo Company		078716293	label, manufacture, pack

Establishment
Name	Address	ID/FEI	Business Operations
Kongo Chemical Co., Ltd.		690908686	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Wanbury Limited		650449981	api manufacture