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NDC 54738-0116-01 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 Richmond Pharmaceuticals Inc.. 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: 54738-0116-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	54738-0116
Product ID	54738-116_9a63ba0a-0e06-744b-e053-2a95a90a9344
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	Richmond Pharmaceuticals Inc.
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 54738-0116-01 (54738011601)

Pricing Information	N/A
NDC Package Code	54738-116-01
Billing NDC	54738011601
Package	100 CAPSULE in 1 BOTTLE (54738-116-01)
Marketing Start Date	2015-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f184b2aa-91a4-44f9-b688-d4e318181984 Details

Drug Facts

Active ingredient

(in each capsule)

Diphenhydramine HCl 25 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 tranquilizers

When using this product

you may get very drowsy
avoid alcoholic drinks
alcohol, sedatives & 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 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 1 to 2 capsules every 4 to 6 hours; not more than 6 doses in 24 hours
children under 12 years: ask a doctor

Other information

store at 15-30°C(59-86°F)
protect from moisture

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 804-270-4498, 8:30 am - 4:30 pm ET, Monday – Friday

TAMPER EVIDENT: DO NOT USE IF BLISTER PACK IS TORN OR DAMAGED

*Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the trademark BENADRYL® Allergy.

Distributed by: Richmond Pharmaceuticals Inc., Richmond, VA 23233 Made in USA

RI1010

Principle Display Panel

Richmond Pharmaceuticals, Inc.

*Compare to active ingredient in BENADRYL® Allergy

Diphenhydramine HCI Capsules, USP

25 mg

50 mg

ANTIHISTAMINE

100 CAPSULES (10 x 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-115
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
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 (pink, natural)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP;20
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54738-115-13	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2000

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/15/2000

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-116
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 (pink, pink)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP;21
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54738-116-13	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2000

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/15/2000

Labeler - Richmond Pharmaceuticals Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-115, 54738-116)

Revised: 12/2019

Document Id: 9a63ba0a-0e06-744b-e053-2a95a90a9344

Set id: f184b2aa-91a4-44f9-b688-d4e318181984

Version: 4

Effective Time: 20191223

Search by Drug Name or NDC

NDC 54738-0116-01 Diphenhydramine Hydrochloride 50 mg/1 Details

Diphenhydramine Hydrochloride 50 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 54738-0116-01 (54738011601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f184b2aa-91a4-44f9-b688-d4e318181984 Details

Active ingredient

Purpose

Uses

Warnings

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

If pregnant or breast-feeding,

Keep out of reach of children.

Inactive ingredients

Questions or comments?

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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