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NDC 71335-0435-05 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 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: 71335-0435-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	71335-0435
Product ID	71335-0435_b5a7fa2e-d908-49b7-8441-72a692a02614
Associated GPIs	41200030100105
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 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	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	2023-12-31

Package

Package Images

NDC 71335-0435-05 (71335043505)

Pricing Information	N/A
NDC Package Code	71335-0435-5
Billing NDC	71335043505
Package	15 CAPSULE in 1 BOTTLE (71335-0435-5)
Marketing Start Date	2019-01-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b5a7fa2e-d908-49b7-8441-72a692a02614 Details

Active Ingredient (in each banded capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

25 MG

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

50 MG

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

25 MG

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

50 MG

to make a child sleepy
with any other product containing diphenhydramine, including one applied topically

Ask a doctor before use if you have

25 MG

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

50 MG

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

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

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

25 MG

adults and children 12 years of age and over	1 to 2 capsules
children 6 years to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

50 MG

adults and children 12 years of age and over	1 capsule
children 6 years to under 12 years of age	Ask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
Protect from moisture
Contains lactose

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

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

HOW SUPPLIED

NDC: 71335-0435-1: 30 Tablets in a BOTTLE

NDC: 71335-0435-2: 20 Tablets in a BOTTLE

NDC: 71335-0435-3: 42 Tablets in a BOTTLE

NDC: 71335-0435-4: 24 Tablets in a BOTTLE

NDC: 71335-0435-5: 15 Tablets in a BOTTLE

NDC: 71335-0435-6: 60 Tablets in a BOTTLE

NDC: 71335-0435-7: 10 Tablets in a BOTTLE

NDC: 71335-0435-8: 6 Tablets in a BOTTLE

NDC: 71335-0435-9: 90 Tablets in a BOTTLE

NDC: 71335-0435-0: 100 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Diphenhydramine 25mg Capsule

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0435(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
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)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink (half pink and half clear with white powder inside)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;835
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0435-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2018
2	NDC:71335-0435-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2018
3	NDC:71335-0435-3	42 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
4	NDC:71335-0435-4	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2019
5	NDC:71335-0435-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	01/28/2019
6	NDC:71335-0435-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2020
7	NDC:71335-0435-7	10 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
8	NDC:71335-0435-8	6 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
9	NDC:71335-0435-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
10	NDC:71335-0435-0	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2019

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

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0435) , RELABEL(71335-0435)

Revised: 2/2022

Document Id: b5a7fa2e-d908-49b7-8441-72a692a02614

Set id: b5a7fa2e-d908-49b7-8441-72a692a02614

Version: 6

Effective Time: 20220209

Search by Drug Name or NDC

NDC 71335-0435-05 Diphenhydramine Hydrochloride 25 mg/1 Details

Diphenhydramine Hydrochloride 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71335-0435-05 (71335043505)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b5a7fa2e-d908-49b7-8441-72a692a02614 Details

Active Ingredient (in each banded capsule)

Purpose

Use

WARNINGS

Ask a doctor before use if you have

Ask a doctor or pharmacist

When using this product

If pregnant or breast-feeding

KEEP OUT OF REACH OF CHILDREN

Directions

Other Information

Inactive Ingredients

Questions?

Distributed by

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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