diphenhydramine hcl 25mg & 50mg caps

diphenhydramine hcl 25mg & 50mg caps
SPL v4
SPL
SPL Set ID 365bb414-8425-a900-e063-6394a90aa887
Route
oral
Published
Effective Date 2025-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
silicon dioxide gelatin lactose monohydrate magnesium stearate microcrystalline cellulose

Identifiers & Packaging

Pill Appearance
Imprint: AD50 Shape: capsule Color: pink Size: 15 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-05-30
Purpose

Antihistamine

Description

Diphenhydramine Hydrochloride 25 mg and 50 mg

Medication Information

Uses

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
Purpose

Antihistamine

Directions
  • take every 4 to 6 hours 
  • do not take more than 6 doses in 24 hours

25 mg Dosage:

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

50 mg Dosage:

 Age  Dose
 adults and children 12 years and over  1 capsules
 children under 12 years of age  ask a doctor, the proper dosage

strength is not available in this

package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the

25 mg. package.

Other Information
  • store at room temperature 20 º-25 ºC(68 º-77 ºF)
  • do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • protect from moisture
Inactive Ingredients

Colloidal silicon dioxide, Gelatin, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose

Description

Diphenhydramine Hydrochloride 25 mg and 50 mg

Section 51945-4

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

Call toll-free 1-877-225-6999

Manufactured for:

AARNA USA INC

Leland, NC 28451

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Active Ingredient (in Each Banded Capsule)

Diphenhydramine Hydrochloride 25 mg and 50 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

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
Purpose

Antihistamine

Directions
  • take every 4 to 6 hours 
  • do not take more than 6 doses in 24 hours

25 mg Dosage:

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

50 mg Dosage:

 Age  Dose
 adults and children 12 years and over  1 capsules
 children under 12 years of age  ask a doctor, the proper dosage

strength is not available in this

package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the

25 mg. package.

Other Information (Other information)
  • store at room temperature 20 º-25 ºC(68 º-77 ºF)
  • do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, Gelatin, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose

Section 51945-4 (51945-4)

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-225-6999

Manufactured for:

AARNA USA INC

Leland, NC 28451

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Active Ingredient (in Each Banded Capsule) (Active ingredient (in each banded capsule))

Diphenhydramine Hydrochloride 25 mg and 50 mg

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:12.304760 · Updated: 2026-03-14T23:08:52.632356