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NDC 71335-0526-03 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 Bryant Ranch Prepack. 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: 71335-0526-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	71335-0526
Product ID	71335-0526_c7aaaf9a-f499-4347-907d-383c38b5f1e2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Bryant Ranch Prepack
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 71335-0526-03 (71335052603)

Pricing Information	N/A
NDC Package Code	71335-0526-3
Billing NDC	71335052603
Package	30 CAPSULE in 1 BOTTLE (71335-0526-3)
Marketing Start Date	2010-01-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d90fb5a8-2a57-42b7-8efb-204c701e2579 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 haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf 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 hoursDo not take more than 6 doses in 24 hours.Adults and children 12 years or over1 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

HOW SUPPLIED

Product: 71335-0526

NDC: 71335-0526-1 15 CAPSULE in a BOTTLE

NDC: 71335-0526-2 20 CAPSULE in a BOTTLE

NDC: 71335-0526-3 30 CAPSULE in a BOTTLE

NDC: 71335-0526-4 10 CAPSULE in a BOTTLE

NDC: 71335-0526-5 6 CAPSULE in a BOTTLE

NDC: 71335-0526-6 100 CAPSULE in a BOTTLE

NDC: 71335-0526-7 90 CAPSULE in a BOTTLE

NDC: 71335-0526-8 60 CAPSULE in a BOTTLE

NDC: 71335-0526-9 2 CAPSULE in a BOTTLE

NDC: 71335-0526-0 12 CAPSULE in a BOTTLE

Diphenhydramine 50mg Capsule

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL

diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0526(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:71335-0526-1	15 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010
2	NDC:71335-0526-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010
3	NDC:71335-0526-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010
4	NDC:71335-0526-4	10 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010
5	NDC:71335-0526-5	6 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010
6	NDC:71335-0526-6	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010
7	NDC:71335-0526-7	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010
8	NDC:71335-0526-8	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010
9	NDC:71335-0526-9	2 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010
10	NDC:71335-0526-0	12 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2010

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

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0526) , RELABEL(71335-0526)

Revised: 1/2020

Document Id: c7aaaf9a-f499-4347-907d-383c38b5f1e2

Set id: d90fb5a8-2a57-42b7-8efb-204c701e2579

Version: 10

Effective Time: 20200106