Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride
SPL v1
SPL
SPL Set ID 2754748f-710b-632e-e063-6294a90a58fd
Route
ORAL
Published
Effective Date 2024-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: PC11 Shape: capsule Color: purple Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-30
Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 34088-5

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take only one dose per day (24 hours)
adults and children 12 years and over 2 softgels at bedtime if needed or as directed by a doctor
children under12 years do not use

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • store at room temperature 15°-30° C (59°-86° F)
  • avoid excessive heat above 40° C (104° F)
  • protect from light
Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Nighttime SLEEP-AID

Diphenhydramine HCl 25mg

100 SOFTGELS

Compare to Active Ingredient in VICKS ® ZzzQuil TM NIGHTTIME SLEEP-AID LiquiCaps TM

NDC 51013-181-01

When Using This Product
  • avoid alcoholic drinks
Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Structured Label Content

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nighttime sleep-aid

Directions
  • take only one dose per day (24 hours)
adults and children 12 years and over 2 softgels at bedtime if needed or as directed by a doctor
children under12 years do not use

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • store at room temperature 15°-30° C (59°-86° F)
  • avoid excessive heat above 40° C (104° F)
  • protect from light
Inactive Ingredients (Inactive ingredients)

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Nighttime SLEEP-AID

Diphenhydramine HCl 25mg

100 SOFTGELS

Compare to Active Ingredient in VICKS ® ZzzQuil TM NIGHTTIME SLEEP-AID LiquiCaps TM

NDC 51013-181-01

When Using This Product (When using this product)
  • avoid alcoholic drinks
Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:33.840027 · Updated: 2026-03-14T23:05:23.931529