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NDC 47682-0184-64 Medique Diphen 25 mg/1 Details

Medique Diphen 25 mg/1

Medique Diphen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. 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: 47682-0184-64
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	47682-0184
Product ID	47682-184_da445fa6-f486-8210-e053-2995a90ae205
Associated GPIs	41200030100305
GCN Sequence Number	011594
GCN Sequence Number Description	diphenhydramine HCl TABLET 25 MG ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	46071
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	Medique Diphen
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	Unifirst First Aid Corporation
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	n/a

Package

Package Images

NDC 47682-0184-64 (47682018464)

Pricing Information	N/A
NDC Package Code	47682-184-64
Billing NDC	47682018464
Package	24 PACKET in 1 BOX (47682-184-64) / 1 TABLET, FILM COATED in 1 PACKET
Marketing Start Date	2012-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b61ee2e0-2543-447d-9fc4-23363d46ce04 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

SPL UNCLASSIFIED SECTION

Purpose

Antihistamine

SPL UNCLASSIFIED SECTION

Uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies

runny nose
sneezing
itching of the nose or throat
itchy-watery eyes

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 that is used on skin.

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

■ glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

marked drowsiness may occur
avoid alcohol beverages
alcohol, sedatives and tranquilizers may increase drowsiness
use caution 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 the reach of children.

In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

SPL UNCLASSIFIED SECTION

Directions

take every 4-6 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 caplets

Children under 12 years: do not use

SPL UNCLASSIFIED SECTION

Other information

store at room temperature 68º-77ºF (20º-25ºC)
protect from light
tamper-evident sealed packets
do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Inactive ingredients

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

SPL UNCLASSIFIED SECTION

Questions or comments? 1-800- 634-7680

184R Medique Diphen Label

Collect MediBucks See inside flap for more details

Medique®

Diphen

Hay Fever / Allergies

Fiebre del Heno / Alergias

This Package is for Households without Young Children.

Este Paquete Es Para Hogares Sin Ninos Pequenos.

Antihistamine • Diphenhydramine HCl 25 mg

Antihistaminico • Hidrocloruro de Difenhidramina 25mg

200 Caplets

(200 x 1)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

Medique 167 Diphen Principal Display Panel

Collect MediBucks See inside flap for more details

Medique®

Diphen

Hay Fever / Allergies

Fiebre del Heno / Alergias

This Package is for Households without Young Children.

Este Paquete Es Para Hogares Sin Ninos Pequenos.

Antihistamine • Diphenhydramine HCl 25 mg

Antihistaminico • Hidrocloruro de Difenhidramina 25mg

200 Caplets

(200 x 1)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

INGREDIENTS AND APPEARANCE

MEDIQUE DIPHEN

diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-184
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	061;T
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47682-184-32	12 in 1 BOX	01/01/2012	11/01/2012
1	NDC:47682-184-46	1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC:47682-184-64	24 in 1 BOX	01/01/2012	08/01/2023
2		1 in 1 PACKET; Type 0: Not a Combination Product
3	NDC:47682-184-47	200 in 1 BOX	01/01/2012	08/01/2023
3		1 in 1 PACKET; Type 0: Not a Combination Product
4	NDC:47682-184-46	1 in 1 PACKET; Type 0: Not a Combination Product	01/01/2012	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2012	08/01/2023

MEDIQUE DIPHEN

diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-167
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	048;D
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47682-167-32	12 in 1 BOX	01/01/2012	11/01/2012
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC:47682-167-64	24 in 1 BOX	01/01/2012
2		1 in 1 PACKET; Type 0: Not a Combination Product
3	NDC:47682-167-47	200 in 1 BOX	01/01/2012
3	NDC:47682-167-46	1 in 1 PACKET; Type 0: Not a Combination Product
4	NDC:47682-167-46	1 in 1 PACKET; Type 0: Not a Combination Product	01/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2012

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 3/2022

Document Id: da445fa6-f486-8210-e053-2995a90ae205

Set id: b61ee2e0-2543-447d-9fc4-23363d46ce04

Version: 14

Effective Time: 20220315

Search by Drug Name or NDC

NDC 47682-0184-64 Medique Diphen 25 mg/1 Details

Medique Diphen 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 47682-0184-64 (47682018464)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b61ee2e0-2543-447d-9fc4-23363d46ce04 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Warnings

Keep out of the reach of children.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

184R Medique Diphen Label

Medique 167 Diphen Principal Display Panel

INGREDIENTS AND APPEARANCE

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