Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID a19f1edc-d2cf-45fc-8233-d882441b0247
Route
ORAL
Published
Effective Date 2025-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Ferrosoferric Oxide D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Lactose Monohydrate Magnesium Stearate Silicon Dioxide Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: PH013 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-10-11

Description

Diphenhydramine HCl 50mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 50mg

Uses
  • temporarily relieves these symptoms due to hay fever  or other upper 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 16103-0347-11

Manufactured in the USA

PHARBEDRYL

Diphenhydramine HCl 50mg

Antihistamine

• Sneezing • Runny Nose

• Itchy, Watery Eyes • Itchy Throat

1000 CAPSULES

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDERN

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin 
Directions

  • take every 4-6 hours or as directed by a doctor
  • do not exceed 6 doses in 24 hours.

Adults and children 12 years and over

1 capsule

Children under 12 years of age

Ask a doctor

Other Information

  • store at 20°-25°C (68-77°F)
Inactive Ingredients

black iron oxide, D & C red #28, FD & 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 EST)

When Using This Product
  • avoid alcoholic drinks
  • drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives & tranquilizers may increase drowsiness

  • use caution 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 50mg

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 upper 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 16103-0347-11

Manufactured in the USA

PHARBEDRYL

Diphenhydramine HCl 50mg

Antihistamine

• Sneezing • Runny Nose

• Itchy, Watery Eyes • Itchy Throat

1000 CAPSULES

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDERN

Purpose

Antihistamine

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin 
Directions

  • take every 4-6 hours or as directed by a doctor
  • do not exceed 6 doses in 24 hours.

Adults and children 12 years and over

1 capsule

Children under 12 years of age

Ask a doctor

Other Information (Other information)

  • store at 20°-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

black iron oxide, D & C red #28, FD & 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 EST)

When Using This Product (When using this product)
  • avoid alcoholic drinks
  • drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives & tranquilizers may increase drowsiness

  • use caution 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 50mg

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

All Sections (JSON)