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Medique at Home Diphen

Medique @ Home Diphen Caplet

Approved
Approval ID

b56d1966-efd7-56eb-e053-2995a90a89b5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 19, 2025

Manufacturers
FDA

Unifirst First Aid Corporation

DUNS: 832947092

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diphenhydramine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47682-166
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2025
FDA Product Classification

INGREDIENTS (10)

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/2/2020

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

MDQ

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/2/2020

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 12/2/2020

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/2/2020

Active ingredient (in each caplet)

Diphenhydramine Hydrochloride 25 mg

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 12/2/2020

Do not use

■ to make a child sleepy

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 12/2/2020

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 - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/2/2020

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).

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/2/2020

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/2/2020

Purpose

Antihistamine

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 12/2/2020

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

WARNINGS SECTION

LOINC: 34071-1Updated: 12/2/2020

Warnings

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 12/2/2020

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 - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 12/2/2020

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/2/2020

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/2/2020

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

LOINC: 53413-1Updated: 12/2/2020

Questions or comments? 1-800-634-7680

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Medique at Home Diphen - FDA Drug Approval Details