Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 3ac0beba-303d-404e-bfec-0cf8c0e8624d
Route
ORAL
Published
Effective Date 2025-03-27
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: PH013 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-01-27
Description

Diphenhydramine HCL 25 mg Diphenhydramine HCL 50 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCL 25 mg 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.

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 to 2 capsule                                     

Children 6 to under 12 years

1 capsule

Children under 6 years

ask a doctor
Other Information:
  • •
    Store at room temperature 15-30 degrees C (59-86 degrees F)
  • •
    Protect from excessive moisture
Principal Display Panel
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 25 mg

Diphenhydramine HCL 50 mg

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 Dioxid, Sodium Lauryl Sulfate

Relabeled By: Preferred Pharmaceuticals Inc.

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.

Purpose

Antihistamine

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 to 2 capsule                                     

Children 6 to under 12 years

1 capsule

Children under 6 years

ask a doctor
Other Information: (Other information:)
  • •
    Store at room temperature 15-30 degrees C (59-86 degrees F)
  • •
    Protect from excessive moisture
Principal Display Panel
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 25 mg

Diphenhydramine HCL 50 mg

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 Dioxid, 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 Dioxid, Sodium Lauryl Sulfate)

Relabeled By: Preferred Pharmaceuticals Inc.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:48.389287 · Updated: 2026-03-14T23:08:08.103878