SPL v31
SPL
SPL Set ID d38f47ea-7fda-170b-e053-2995a90adc82
Route
ORAL
Published
Effective Date 2025-06-24
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 Lecithin, Soybean Silicon Dioxide Magnesium Stearate Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified D&c Red No. 27 Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: D25 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-24

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

Do not use

  • To make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin

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

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

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

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.

Other Information
  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Read all product information before use.
Inactive Ingredients:

May Contains:

Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, D&C Red 27, Polyvinyl alcohol, Talc, Titanium dioxide, Polyethylene Glycol, Lecithin, Purified waer.

Questions Or Comments?

Call toll free  1-844-832-1138

Monday through Friday 9AM- 5PM EST

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

Package Label.principal Display Panel 100 Count

Package Label.principal Display Panel 300 Count

Package Label.principal Display Panel 600 Count

Package Label.principal Display Panel 1000 Count


Structured Label Content

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

Antihistamine

Warnings

Do not use

  • To make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin

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

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

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

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.

Other Information
  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Read all product information before use.
Inactive Ingredients:

May Contains:

Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, D&C Red 27, Polyvinyl alcohol, Talc, Titanium dioxide, Polyethylene Glycol, Lecithin, Purified waer.

Questions Or Comments? (Questions or comments?)

Call toll free  1-844-832-1138

Monday through Friday 9AM- 5PM EST

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

Package Label.principal Display Panel 100 Count (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-100 count)

Package Label.principal Display Panel 300 Count (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-300 count)

Package Label.principal Display Panel 600 Count (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-600 count)

Package Label.principal Display Panel 1000 Count (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1000 count)


Advanced Ingredient Data


Raw Label Data

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