Search by Drug Name or NDC

NDC 63187-0866-30 Diphenhydramine HCL 50 mg/1 Details

Diphenhydramine HCL 50 mg/1

Diphenhydramine HCL is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0866-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	63187-0866
Product ID	63187-866_02f87529-6ca5-4107-a6d1-af756b9b8a59
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 HCL
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCL
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	Proficient Rx LP
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 63187-0866-30 (63187086630)

Pricing Information	N/A
NDC Package Code	63187-866-30
Billing NDC	63187086630
Package	30 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-30)
Marketing Start Date	2017-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 Details

Active ingredient(in each capsule)

Diphenhydramine HCL 50 mg

Purpose

Antihistamine

Uses:

•: Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
•: Sneezing.
•: Nasal congestion.
•: Runny nose.
•: Itchy, watery eyes.

Warnings:

Do not use

•: With any other product containing Diphenhydramine HCL, including one applied topically.

Ask a doctor or pharmacist before use

If you have

•: Trouble urinating due to enlarged prostate gland
•: A breathing problem such as emphysema or chronic bronchitis
•: Glaucoma
•: If you are taking sedatives or tranquilizers

When using this product

•: Avoid alcoholic drinks.
•: Marked drowsiness may occur.
•: Excitability may occur, especially in children.
•: Alcohol, sedatives and tranquilizers may increase drowsiness.
•: Be careful when driving a motor vehicle or operating machinery.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

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

Directions:

•: Take every 4-6 hours
•: Do not take more than 6 doses in 24 hours.

Adults and children 12 years or over	1 capsule
Children under 12 years	ask a doctor

**25 mg strength is not available in this package. Do not attempt to break capsules.

Other information:

•: Store at room temperature 15-30 degrees C (59-86 degrees F)
•: Protect from excessive moisture

Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

Questions? Adverse drug event call:

1-800-687-0176

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL

diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-866(NDC:66424-021)
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PH013
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-866-10	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/10/2020
2	NDC:63187-866-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2017
3	NDC:63187-866-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2017
4	NDC:63187-866-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/27/2010

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-866)

Revised: 10/2021

Document Id: 02f87529-6ca5-4107-a6d1-af756b9b8a59

Set id: 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8

Version: 4

Effective Time: 20211001