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NDC 66267-0080-20 Diphenhydramine HCL 25 mg/1 Details

Diphenhydramine HCL 25 mg/1

Diphenhydramine HCL is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by NuCare 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: 66267-0080-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	66267-0080
Product ID	66267-080_e767c105-d9e1-7162-e053-2a95a90afc9d
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 HCL
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCL
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	NuCare 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 66267-0080-20 (66267008020)

Pricing Information	N/A
NDC Package Code	66267-080-20
Billing NDC	66267008020
Package	20 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-20)
Marketing Start Date	2016-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3dbdf67f-766b-12ee-e054-00144ff8d46c Details

Active ingredient(in each capsule)

Diphenhydramine HCL 25 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 to 2 capsule
Children 6 to under 12 years	1 capsule
Children under 6 years	ask a doctor

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL

diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66267-080(NDC:66424-020)
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 (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PH014
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66267-080-15	15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2016
2	NDC:66267-080-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2016
3	NDC:66267-080-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2016
4	NDC:66267-080-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2016
5	NDC:66267-080-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2016
6	NDC:66267-080-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2016

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

Labeler - NuCare Pharmaceuticals, Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals, Inc.		010632300	repack(66267-080)

Revised: 8/2022

Document Id: e767c105-d9e1-7162-e053-2a95a90afc9d

Set id: 3dbdf67f-766b-12ee-e054-00144ff8d46c

Version: 5

Effective Time: 20220829