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NDC 42806-0649-10 Diphenhydramine Hydrochloride 50 mg/1 Details

Diphenhydramine Hydrochloride 50 mg/1

Diphenhydramine Hydrochloride is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Epic Pharma, LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 42806-0649-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	42806-0649
Product ID	42806-649_4884641f-c4af-4148-89c1-0e29c6ec6e5e
Associated GPIs	41200030100110
GCN Sequence Number	011583
GCN Sequence Number Description	diphenhydramine HCl CAPSULE 50 MG ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	45972
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	Diphenhydramine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Epic Pharma, LLC
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 42806-0649-10 (42806064910)

Pricing Information
NDC Package Code	42806-649-10
Billing NDC	42806064910
Package	1000 CAPSULE in 1 BOTTLE (42806-649-10)
Marketing Start Date	2016-11-22
NDC Exclude Flag	N
Price Per Unit	0.0202
Pricing Unit	EA
Effective Date	2022-11-23
NDC Description	DIPHENHYDRAMINE 50 MG CAPSULE
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 15437a72-24e5-4ef2-b1ea-8d8c0acbcd4c Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Epic Pharma, LLC (827915443)

Revised: 11/2016

Document Id: 4884641f-c4af-4148-89c1-0e29c6ec6e5e

Set id: 15437a72-24e5-4ef2-b1ea-8d8c0acbcd4c

Version: 1

Effective Time: 20161122