Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride
SPL v5
SPL
SPL Set ID 82771f6a-8b3d-4ffa-8b35-09c2faf3582c
Route
ORAL
Published
Effective Date 2018-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Polyethylene Glycol 400 Polysorbate 80 Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide Xanthan Gum Carnauba Wax Silicon Dioxide Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-09
Description

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine hydrochloride 25 mg

Uses

temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract

  • runny nose
  • sneezing
  • Itchy watery eyes
  • Itching of the nose or throat.
Warnings

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin.
Drug Facts

Directions:
  • take every 4 to 6 hours
  • do not take more than 6 does in 24 hours
  • Adult and children 12 years of age and over - 1 to 2 tablet
  • Children 6 to 12 years of age - 1 tablet
  • Children 6 years of age - do not use this product in children under 6 years
Other Information
  • each tablet contains: Calcium 25 mg/tablet
  • store at room temperature 15°-30° (59°-86° F)
  • protect from light and moisture
Package Labeling:

Inactive Ingredient

carnauba wax, colloidal anhydrous silica, croscarmellose sodium, dibasic calcium phosphate, hydroxy propyl methyl cellulose phthalate HP-55, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, xanthan gum,

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Or Reach of Children.

In case of overdose, get medical help or contact a poison control center right away.

Consult Your Doctor If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland.
Active Ingredient (in Each Tablet)

Diphenhydramine hydrochloride 25 mg

Consult Your Doctor If You Are Taking Sedatives Or Tranquilizers
  • sedative, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur especially in children.

Structured Label Content

Uses

temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract

  • runny nose
  • sneezing
  • Itchy watery eyes
  • Itching of the nose or throat.
Purpose

Antihistamine

Warnings

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin.
Drug Facts

Directions:
  • take every 4 to 6 hours
  • do not take more than 6 does in 24 hours
  • Adult and children 12 years of age and over - 1 to 2 tablet
  • Children 6 to 12 years of age - 1 tablet
  • Children 6 years of age - do not use this product in children under 6 years
Other Information
  • each tablet contains: Calcium 25 mg/tablet
  • store at room temperature 15°-30° (59°-86° F)
  • protect from light and moisture
Package Labeling:

Inactive Ingredient (Inactive ingredient)

carnauba wax, colloidal anhydrous silica, croscarmellose sodium, dibasic calcium phosphate, hydroxy propyl methyl cellulose phthalate HP-55, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, xanthan gum,

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks.
If Pregnant Or Breast Feeding, (If Pregnant or breast-feeding,)

ask a health professional before use.

Keep Out Or Reach of Children. (Keep out or reach of children.)

In case of overdose, get medical help or contact a poison control center right away.

Consult Your Doctor If You Have (Consult your doctor if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland.
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine hydrochloride 25 mg

Consult Your Doctor If You Are Taking Sedatives Or Tranquilizers (Consult your doctor if you are taking sedatives or tranquilizers)
  • sedative, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur especially in children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:25.391300 · Updated: 2026-03-14T23:01:57.446196