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NDC 71205-0315-02 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 Proficient Rx LP. 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: 71205-0315-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	71205-0315
Product ID	71205-315_22b06394-9c55-4a5b-b70b-e42b1b2ab474
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	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	Proficient Rx LP
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 71205-0315-02 (71205031502)

Pricing Information	N/A
NDC Package Code	71205-315-02
Billing NDC	71205031502
Package	2 TABLET, FILM COATED in 1 PACKET (71205-315-02)
Marketing Start Date	2019-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 31d96c3e-f5f2-41c2-865a-f49b910ddc77 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Uses

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

•: runny nose
•: sneezing
•: itching 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
•: difficulty in urination due to enlargement of the 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 the drowsiness effect
•: 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 immediately.

Directions

•: do not use more than directed

Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

•: each caplet may contain: calcium 25mg
•: protect from light
•: use by expiration date on packet
•: store at room temperature 59º-86ºF (15º-30ºC
•: tamper-evident sealed packets
•: do not use any opened or torn packets

Inactive ingredients

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide

* may contain

Questions or comments?

1-800- 634-7680

184R Medique Diphen Label

71205-315-06

Diphen

Hay Fever / Allergies

Fiebre del Heno / Alergias

Antihistamine • Diphenhydramine HCl 25 mg

Pull to Open

Tire Para Abrir

Antihistomine • Diphenhydramine HCl 25mg

Antihistaminico • Hidrocloruro de Difenhidramina

Empaquetado con Sellado Evidente en Dosis Unitarias

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

MEDIQUE DIPHEN

diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-315(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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (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
Packaging
1	NDC:71205-315-02	2 in 1 PACKET; Type 0: Not a Combination Product	09/01/2019
2	NDC:71205-315-06	6 in 1 PACKET; Type 0: Not a Combination Product	10/01/2019

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

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-315) , RELABEL(71205-315)

Revised: 1/2021

Document Id: 22b06394-9c55-4a5b-b70b-e42b1b2ab474

Set id: 31d96c3e-f5f2-41c2-865a-f49b910ddc77

Version: 3

Effective Time: 20210101