SPL v1
SPL
SPL Set ID a73d20df-3df7-42f7-8c88-93fee7e9ccec
Route
ORAL
Published
Effective Date 2025-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Anhydrous Dibasic Calcium Phosphate Microcrystalline Cellulose Croscarmellose Sodium Silicon Dioxide Magnesium Stearate D&c Red No. 27 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: D25 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-17
Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Uses:
  • Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.
Warnings

Directions

Adults and children 12 years  and over:1 or 2 caplet (s)

Children 6 to under 12 years of age:1 caplet

Children under 6 years of age:do not use; Do not take more than 6 caplets a day.

Do Not Use
  • To make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin.
Other Information
  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Read all product information before use.
Inactive Ingredients:

Colloidal silicon Dioxide, Croscarmellose sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), D&C Red 27,  Titanium dioxide.

Questions Or Comments?

Call toll free  1-844-832-1138

Monday through Friday 9AM- 5PM EST

When Using This Product
  • Marked drowsiness may occur.
  • Avoid alcoholic drinks, may cause drowsy.
  • Excitability may occur, especially in children.
  • Be careful when driving a motor vehicle or operating machinery.
Stop Use and Ask Doctor If 

symptoms not relieved within seven days usage, please contact physician or health care provider.

If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • Trouble urinating due to an enlarged prostate gland
  • Glaucoma
  • A breathing problem such as emphysema or chronic bronchitis
Principal Display Panel 100 Caplets

Principal Display Panel 300 Caplets

Principal Display Panel 600 Caplets

Principal Display Panel 1000 Caplets

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses:
  • Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.
Purpose

Antihistamine

Warnings

Directions

Adults and children 12 years  and over:1 or 2 caplet (s)

Children 6 to under 12 years of age:1 caplet

Children under 6 years of age:do not use; Do not take more than 6 caplets a day.

Do Not Use (Do not use)
  • To make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin.
Other Information
  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Read all product information before use.
Inactive Ingredients:

Colloidal silicon Dioxide, Croscarmellose sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), D&C Red 27,  Titanium dioxide.

Questions Or Comments? (Questions or comments?)

Call toll free  1-844-832-1138

Monday through Friday 9AM- 5PM EST

When Using This Product (When using this product)
  • Marked drowsiness may occur.
  • Avoid alcoholic drinks, may cause drowsy.
  • Excitability may occur, especially in children.
  • Be careful when driving a motor vehicle or operating machinery.
Stop Use and Ask Doctor If  (Stop use and ask doctor if )

symptoms not relieved within seven days usage, please contact physician or health care provider.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

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

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • Trouble urinating due to an enlarged prostate gland
  • Glaucoma
  • A breathing problem such as emphysema or chronic bronchitis
Principal Display Panel 100 Caplets (PRINCIPAL DISPLAY PANEL-100 Caplets)

Principal Display Panel 300 Caplets (PRINCIPAL DISPLAY PANEL-300 Caplets)

Principal Display Panel 600 Caplets (PRINCIPAL DISPLAY PANEL-600 Caplets)

Principal Display Panel 1000 Caplets (PRINCIPAL DISPLAY PANEL-1000 Caplets)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:03.536576 · Updated: 2026-03-14T23:10:14.816739