Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 070e556b-e083-452f-8a7c-aca92470dd61
Route
ORAL
Published
Effective Date 2025-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Ferrosoferric Oxide D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Lactose Monohydrate Magnesium Stearate Silicon Dioxide Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: PH014 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-01

Description

Diphenhydramine HCl 25mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25mg

Uses
  • Temporarily relieves these symptoms due to hay fever or other respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • Temporarily relieves these symptoms due to common cold:
  • runny nose
  • sneezing
Section 51945-4

PHARBEST

NDC 16103-0348-11

Manufactured in the USA

* Compare to the active ingredient in Benadryl® Ultratabs

PHARBEDRYL

Diphenhydramine HCl 25mg

Antihistamine

• Sneezing                      • Runny Nose

• Itchy, Watery Eyes      • Itchy Throat

1000 CAPSULES

This Package for Households without Young Childern

Warnings

Do not use

  • to make child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and above 1-2 Capsules       
children 6 to under 12 years  1 Capsule
children under 6 years Ask a doctor

Other Information
  • store between 20°-25°C (68°-77°F), excursions permitted between 15-30°C (59-86°F)
  • protect from excessive moisture
Inactive Ingredients

black iron oxide, D&C red #28, D&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Questions Or Comments?

(866)562-2756 Mon - Fri 8 AM to 4 PM

When Using This Product
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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 right away (1-800-222-1222).

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 25mg

Ask A Doctor Before Use If You Have
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
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 respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • Temporarily relieves these symptoms due to common cold:
  • runny nose
  • sneezing
Section 51945-4 (51945-4)

PHARBEST

NDC 16103-0348-11

Manufactured in the USA

* Compare to the active ingredient in Benadryl® Ultratabs

PHARBEDRYL

Diphenhydramine HCl 25mg

Antihistamine

• Sneezing                      • Runny Nose

• Itchy, Watery Eyes      • Itchy Throat

1000 CAPSULES

This Package for Households without Young Childern

Purpose

Antihistamine

Warnings

Do not use

  • to make child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and above 1-2 Capsules       
children 6 to under 12 years  1 Capsule
children under 6 years Ask a doctor

Other Information (Other information)
  • store between 20°-25°C (68°-77°F), excursions permitted between 15-30°C (59-86°F)
  • protect from excessive moisture
Inactive Ingredients (Inactive ingredients)

black iron oxide, D&C red #28, D&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Questions Or Comments? (Questions or comments?)

(866)562-2756 Mon - Fri 8 AM to 4 PM

When Using This Product (When using this product)
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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 right away (1-800-222-1222).

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 25mg

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

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