DIPHENHYDRAMINE HYDROCHLORIDE capsule

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Epic Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH CAPSULE)

Diphenhydramine HCl 50 mg

PURPOSE

Antihistamine

USES

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy nose or throat
• itchy, watery eyes

WARNINGS

​Do not use​ with any other product containing diphenhydramine, even one used on skin

​Ask a doctor before use if you have

• ​glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

​Ask a doctor or pharmacist before use if you are​ taking sedatives or tranqulizers

​When using this product

• ​you may get very drowsy
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

​If pregnant or breast-feeding​, ask a health professional before use.

​

KEEP OUT OF THE REACH OF CHILDREN.

In case of overdose, get medical help or contact a Poison Control Venter right away.

DIRECTIONS

• adults & children 12 years and over: take 1 capsule every 4-6 hours; not more than 6 does in 24 hours
• ​children under 12 years: ask a doctor

OTHER INFORMATION

• store at 15°-30°C (59°-86°F)
• protect from moisture
• This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

INACTIVE INGREDIENTS

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

QUESTIONS OR COMMENTS?

call ​888-374-279​ 1, 8:30 am - 4:30 pm ET, Monday - Friday

​TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFTEY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

​Distributed by:

Epic Pharma, LLC

Laurelton, NY

11413

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 50 MG

​Diphenhydramine HCl Capsules, USP​ ​50 mg

​ANTIHISTAMINE

​1000 Capsules

​THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42806-649
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink	Score	no score
Shape	capsule	Size	14mm
Flavor		Imprint Code	AP;021
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42806-649-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/22/2016

Labeler - Epic Pharma, LLC (827915443)