Medique @ Home Diphen Caplet

Medique @ Home Diphen Caplet
SPL v6
SPL
SPL Set ID b56d1966-efd7-56eb-e053-2995a90a89b5
Route
ORAL
Published
Effective Date 2020-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Croscarmellose Sodium Titanium Dioxide D&c Red No. 27 Aluminum Lake Magnesium Stearate Cellulose, Microcrystalline Lactose, Unspecified Form Silicon Dioxide Hypromellose, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 048;D Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and Administration

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50567-7

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

Section 50568-5

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

Section 50569-3

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

Section 50570-1

Do not use

■ to make a child sleepy

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

Section 51727-6

Inactive ingredients

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

Section 51945-4

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

Section 53413-1

Questions or comments? 1-800-634-7680

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each caplet)

Diphenhydramine Hydrochloride 25 mg

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use

■ to make a child sleepy

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each caplet)

Diphenhydramine Hydrochloride 25 mg

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:57.417667 · Updated: 2026-03-14T23:10:03.511025