Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 489645ad-d7da-5f52-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2017-02-15
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 2010-01-27
Description

Diphenhydramine HCL 50 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCL 50 mg

Uses:
  • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
  • Sneezing.
  • Nasal congestion.
  • Runny nose.
  • Itchy, watery eyes.

Section 51945-4

Warnings:



Do Not Use
  • With any other product containing Diphenhydramine HCL, including one applied topically.

Directions:
  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours.
Adults and children 12 years or over

1 capsule

Children under 12 years

ask a doctor

**25 mg strength is not available in this package. Do not attempt to break capsules.

Other Information:
  • Store at room temperature 15-30  degrees C (59-86 degrees F)
  • Protect from excessive moisture
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.
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient(in Each Capsule)

Diphenhydramine HCL 50 mg

Questions? Adverse Drug Event Call:

1-800-687-0176

Ask A Doctor Or Pharmacist Before Use

If you have

  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma
  • If you are taking sedatives or tranquilizers
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


Structured Label Content

Uses:
  • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
  • Sneezing.
  • Nasal congestion.
  • Runny nose.
  • Itchy, watery eyes.

Section 51945-4 (51945-4)

Purpose

Antihistamine

Warnings:



Do Not Use (Do not use)
  • With any other product containing Diphenhydramine HCL, including one applied topically.

Directions:
  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours.
Adults and children 12 years or over

1 capsule

Children under 12 years

ask a doctor

**25 mg strength is not available in this package. Do not attempt to break capsules.

Other Information: (Other information:)
  • Store at room temperature 15-30  degrees C (59-86 degrees F)
  • Protect from excessive moisture
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.
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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

Diphenhydramine HCL 50 mg

Questions? Adverse Drug Event Call: (Questions? Adverse drug event call:)

1-800-687-0176

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

If you have

  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma
  • If you are taking sedatives or tranquilizers
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 (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)


Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:24.981498 · Updated: 2026-03-14T23:03:29.554848