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NDC 63187-0771-90 Diphenhydramine Hydrochloride 25 mg/1 Details

Diphenhydramine Hydrochloride 25 mg/1

Diphenhydramine Hydrochloride 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.

Product Information

NDC	63187-0771
Product ID	63187-771_880a5683-eb5b-4576-8218-9da10cbd1789
Associated GPIs	41200030100105
GCN Sequence Number	011582
GCN Sequence Number Description	diphenhydramine HCl CAPSULE 25 MG ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	45971
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	25
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 63187-0771-90 (63187077190)

Pricing Information	N/A
NDC Package Code	63187-771-90
Billing NDC	63187077190
Package	90 CAPSULE in 1 BOTTLE (63187-771-90)
Marketing Start Date	2016-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 278e5b4b-9495-4269-87f2-8897a48ff6f0 Details

Active ingredient

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Use

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

Warnings: Do not use

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

When using this product

• marked drowsiness may occur

• 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

Pregnancy/breast-feeding warning

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

Keep out of reach of children

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

Directions

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours, not more than 12 capsules in 24 hours.

Children 6 years to 12 years of age: take 12.5 mg** (1 capsule) every 4 to 6 hours, not more than 6 capsules in 24 hours.

Children under 6 years of age: do not use

**12.5mg dosage strength is not available in this package. Do not attempt to break capsule

Other information

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature]. Protect from excessive moisture.

Inactive ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Re-Order No. 301574

PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HCL CAPSULES 25MG

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-771(NDC:0904-5306)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
D&C RED NO. 28 (UNII: 767IP0Y5NH)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;835
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-771-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2017
2	NDC:63187-771-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2016
3	NDC:63187-771-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2016
4	NDC:63187-771-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/02/2009

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-771)

Revised: 1/2021

Document Id: 880a5683-eb5b-4576-8218-9da10cbd1789

Set id: 278e5b4b-9495-4269-87f2-8897a48ff6f0

Version: 4

Effective Time: 20210101