Diphenhydramine Hydrochloride Capsules, Usp 25 Mg (purple Transparent)

Diphenhydramine Hydrochloride Capsules, Usp 25 Mg (purple Transparent)
SPL v2
SPL
SPL Set ID 32074a31-326b-4aaf-e063-6394a90a0d40
Route
ORAL
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin Glycerin Polyethylene Glycol 400 Propylene Glycol Sorbitol Water Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: purple Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-07
Description

Diphenhydramine Hydrochloride USP 25mg

Purpose

Antihistamine

Medication Information

Indications and Usage
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing
Purpose

Antihistamine

Description

Diphenhydramine Hydrochloride USP 25mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5

Ask a Doctor or Pharmacist before use if you are taking sedatives or tranquilizers

Section 51945-4

Section 53414-9

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

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
children under 6 years do not use this product in children under 6 years of age

Other Information
  • store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.
  • do not use if carton is open or blister unit is broken
Inactive Ingredients

FD & C blue no.1, FD & C red no.40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

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
Active Ingredient (in Each Softgel)

Diphenhydramine Hydrochloride USP 25mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

Indications and Usage (34067-9)
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5 (50568-5)

Ask a Doctor or Pharmacist before use if you are taking sedatives or tranquilizers

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
children under 6 years do not use this product in children under 6 years of age

Other Information
  • store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.
  • do not use if carton is open or blister unit is broken
Inactive Ingredients

FD & C blue no.1, FD & C red no.40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

When Using This Product (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
Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine Hydrochloride USP 25mg

Ask A Doctor Before Use If You Have (Ask a Doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:22.124653 · Updated: 2026-03-14T23:12:35.594126