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NDC 17714-0135-01 Diphenhydramine Hydrochloride 25 mg/1 Details

Diphenhydramine Hydrochloride 25 mg/1

Diphenhydramine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Advance Pharmaceutical 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: 17714-0135-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	17714-0135
Product ID	17714-135_60f4322f-5c99-096a-e053-2a91aa0a64eb
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
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Advance Pharmaceutical 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 17714-0135-01 (17714013501)

Pricing Information	N/A
NDC Package Code	17714-135-01
Billing NDC	17714013501
Package	100 TABLET in 1 BOTTLE (17714-135-01)
Marketing Start Date	2006-09-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c80f9a4c-1055-45d2-8fde-5b57fad3c82a Details

Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

runny nose
itchy nose or throat
sneezing
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

take every 4-6 hours
do not take more than 6 doses in 24 hours
adults and children 12 years and over : 1-2 tablets
children under 12 years: ask a doctor

Other Information

each tablet contains: calcium 45 mg
store at 15-30 °C (59-86 °F)
protect from moisture

Inactive Ingredients

croscarmellose sodium, D&C red# 27, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, opadry clear, titanium dioxide

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BOKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE TABLETx`, USP 25 MG

ANTIHISTAMINE

NDC: 17714-135-01 – 100 MINI TABLETS

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17714-135
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	AP;135
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:17714-135-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/26/2006

Labeler - Advance Pharmaceutical Inc. (078301063)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(17714-135)

Revised: 12/2017

Document Id: 60f4322f-5c99-096a-e053-2a91aa0a64eb

Set id: c80f9a4c-1055-45d2-8fde-5b57fad3c82a

Version: 2

Effective Time: 20171222