FDA.reportPublic FDA data

Medique at Home Diphen

Manufacturer
Unifirst First Aid Corporation
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:13:01

Label at a glance#

ProductMedique at Home Diphen
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Diphenhydramine Hydrochloride 25 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE 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 SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

■ to make a child sleepy

■ with any other product containing diphenhydramine, even one that is used on skin.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

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 children12 years and over 1 to 2 caplets

Children 6 to under 12 years 1 caplet

Children under 6 years do not use

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 68º-77ºF (20º-25ºC)

■ protect from light

■ TAMPER EVIDENT child resistant packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique® @ Home

Diphen Caplets

Diphenhydramine HCl 25 mg

Antihistamine

Pull to Open

Child-Resistant Packets

*not actual size

50 Packets

(1 Caplet Per Packet)

Compare to the active ingredient in Benadryl® Ultratab® Tablets

MDQMDQ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN6
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-166-46Medique at Home Diphen1 in 1 PACKETTABLET, FILM COATED16
47682-166-50Medique at Home Diphen50 in 1 BOXTABLET, FILM COATED506

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47682-16647682-166-46, 47682-166-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique at Home DiphenDIPHENHYDRAMINE HCLUnifirst First Aid Corporationb56d1966-efd7-56eb-e053-2995a90a89b52025-09-08WarningsExact identifier
ndc (package): 47682-166-50
ndc (package): 47682-166-46
ndc (product): 47682-166
ndc11 (package): 47682016650
ndc11 (package): 47682016646
spl id: 3e4ccd6b-83de-b9f8-e063-6294a90a7b06
spl set id: b56d1966-efd7-56eb-e053-2995a90a89b5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.