medique diphen

medique diphen
SPL v16
SPL
SPL Set ID b61ee2e0-2543-447d-9fc4-23363d46ce04
Route
oral
Published
Effective Date 2021-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
cellulose, microcrystalline croscarmellose sodium d&c red no. 27 hypromelloses lactose magnesium stearate polyethylene glycol, unspecified silicon dioxide titanium dioxide carnauba wax dibasic calcium phosphate dihydrate polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: 061;T Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
otc monograph drug completed Since 2012-01-01 Until 2023-08-01
Description

Drug Facts

Medication Information

Warnings

Warnings

Active Ingredient

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

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 4-6 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50567-7

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
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 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

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

Keep Out of the Reach of Children

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

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

Structured Label Content

Warnings

Warnings

Active Ingredient (55106-9)

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

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 4-6 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

Section 42229-5 (42229-5)

Drug Facts

Section 50567-7 (50567-7)

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
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 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

184r Medique Diphen Label (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

Keep Out of the Reach of Children (Keep out of the reach of children)

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:57.420464 · Updated: 2026-03-14T23:10:03.511025