Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 437e6a13-a4ff-4f98-8973-042f224ee85e
Route
ORAL
Published
Effective Date 2023-06-13
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

NDC 66424-021-10

*Compare to active ingredient in BENADRYL® ALLERGY

Diphenhydramine

HCl Capsules, USP

50 mg

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS MISSING OR DAMAGED

ANTIHISTAMINE

1000 CAPSULES

Not for house holds with young children

SDA

Laboratories, Inc.

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

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 & 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
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

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

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)

NDC 66424-021-10

*Compare to active ingredient in BENADRYL® ALLERGY

Diphenhydramine

HCl Capsules, USP

50 mg

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS MISSING OR DAMAGED

ANTIHISTAMINE

1000 CAPSULES

Not for house holds with young children

SDA

Laboratories, Inc.

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

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 & 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
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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:20.172599 · Updated: 2026-03-14T23:06:59.037711