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NDC 58602-0742-11 Diphenhydramine Hydrochloride 25 mg/1 Details

Diphenhydramine Hydrochloride 25 mg/1

Diphenhydramine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. 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: 58602-0742-11
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	58602-0742
Product ID	58602-742_8b8303ca-136b-4ac4-a5d6-0be1858eb69f
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 Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Aurohealth LLC
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 58602-0742-11 (58602074211)

Pricing Information	N/A
NDC Package Code	58602-742-11
Billing NDC	58602074211
Package	1 BOTTLE in 1 CARTON (58602-742-11) / 36 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2016-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eca90b31-3bb5-40d4-8e87-ad3fcd74f887 Details

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl, USP 25 mg

Purpose

Antihistamine

Uses

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

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

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. (1-800-222-1222)

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

adults and children 12 years and over	1 to 2 tablets
children 6 to under 12 years	1 tablet
children under 6 years	do not use

Other information

each tablet contains: calcium 10 mg
store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
do not use if carton is opened, or seal under cap is torn or missing.

Inactive ingredients

colloidal silicon dioxide, crospovidone, D&C red no. 27 aluminium lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, titanium dioxide

Questions or comments?

1-855-274-4122

* This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allerg Ultra Tabs.

Distributed by:

Aurohealth LLC.

2572 Brunswick Pike

Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg Container Carton (24's Tablets)

AUROHEALTH

NDC 58602-742-07

*Compare to the

active ingredient in

Benadryl®Ultra tabs

Allergy Relief

Aurodryl

Diphenhydramine

Hydrochloride

25 mg Mini Tablets

Antihistamine

Relieves

Sneezing
Runny nose
Itchy, Watery Eyes
Itchy Throat

24

Mini Tablets

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-742
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE (Biconvex)	Size	11mm
Flavor		Imprint Code	T;94
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-742-07	1 in 1 CARTON	03/01/2016
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:58602-742-11	1 in 1 CARTON	03/01/2016
2		36 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:58602-742-13	1 in 1 CARTON	03/01/2016
3		48 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:58602-742-21	1 in 1 CARTON	03/01/2016
4		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	03/01/2016

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
APL HEALTHCARE LIMITED		650844777	MANUFACTURE(58602-742)

Revised: 12/2020

Document Id: 8b8303ca-136b-4ac4-a5d6-0be1858eb69f

Set id: eca90b31-3bb5-40d4-8e87-ad3fcd74f887

Version: 3

Effective Time: 20201204