drug facts

drug facts
SPL v1
SPL
SPL Set ID 17df154b-af18-43ab-ae62-332b33454e4c
Route
oral
Published
Effective Date 2021-10-26
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 final active Since 2010-01-27
Purpose

Antihistamine

How Supplied

Product: 50090-5719 NDC: 50090-5719-0 1 CAPSULE in a BLISTER PACK / 32 in a BOX, UNIT-DOSE

Description

Diphenhydramine HCL 25 mg

Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-5719

NDC: 50090-5719-0 1 CAPSULE in a BLISTER PACK / 32 in a BOX, UNIT-DOSE

Description

Diphenhydramine HCL 25 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.

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 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
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.
Diphenhydramine Hcl Capsule
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

Ask A Doctor Or Pharmacist Before Use

If you haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf 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

Purpose

Antihistamine

How Supplied (HOW SUPPLIED)

Product: 50090-5719

NDC: 50090-5719-0 1 CAPSULE in a BLISTER PACK / 32 in a BOX, UNIT-DOSE

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

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 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
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.
Diphenhydramine Hcl Capsule (DIPHENHYDRAMINE HCL CAPSULE)
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

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

If you haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf 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: 2026-02-15T11:59:46.992547 · Updated: 2026-03-14T22:59:54.471917