Night Time Sleep-aid

Night Time Sleep-aid
SPL v2
SPL
SPL Set ID 07c69e63-deb1-4607-9f7f-1cf0cd05cc82
Route
ORAL
Published
Effective Date 2024-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Microcrystalline Cellulose Anhydrous Dibasic Calcium Phosphate Stearic Acid Croscarmellose Sodium Silicon Dioxide Hypromellose, Unspecified Titanium Dioxide Triacetin Fd&c Red No. 40 Aluminum Lake Fd&c Blue No. 2 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: DPZ Shape: capsule Color: purple Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-08-01 Until 2027-12-31
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 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

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 50567-7

When using this product

  • avoid alcoholic beverages
Section 50568-5

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

Section 50569-3

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
Section 50570-1

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
Section 53414-9

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

Directions

• take only one dose (2 Caplets) per day (24 hours)

adults & children 12 yrs & over 2 Caplets at bedtime if needed or as directed by a doctor
children under 12 yrs do not use

Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSIN
Inactive Ingredients

Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Croscarmellose Sodium, Colloidal Silicon Dioxide, Hypromellose, Titanium Dioxide, Triacetin, FD&C Red No.40 Lake, FD&C Blue No.2 Aluminum Lake, Polysorbate.

Questions Or Comments

Call toll free 1-800-630-8895

Monday through Friday 9AM - 5PM EST

Principal Display Panel

NDC 80513-383-22

Compare to the  active indredient in VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID*

NIGHT TIME SLEEP-AID

Diphenhydramine HCl 25 mg

220 CAPLETS

*This product is not manufactured or distributed by The The Procter & Gamble Company, owner of the registered trademark VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID

Active Ingredients (in Each Caplet)

Diphenhydramine HCl 25 mg

Structured Label Content

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

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 50567-7 (50567-7)

When using this product

  • avoid alcoholic beverages
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
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 (2 Caplets) per day (24 hours)

adults & children 12 yrs & over 2 Caplets at bedtime if needed or as directed by a doctor
children under 12 yrs do not use

Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSIN
Inactive Ingredients (Inactive ingredients)

Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Croscarmellose Sodium, Colloidal Silicon Dioxide, Hypromellose, Titanium Dioxide, Triacetin, FD&C Red No.40 Lake, FD&C Blue No.2 Aluminum Lake, Polysorbate.

Questions Or Comments (Questions or comments)

Call toll free 1-800-630-8895

Monday through Friday 9AM - 5PM EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 80513-383-22

Compare to the  active indredient in VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID*

NIGHT TIME SLEEP-AID

Diphenhydramine HCl 25 mg

220 CAPLETS

*This product is not manufactured or distributed by The The Procter & Gamble Company, owner of the registered trademark VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID

Active Ingredients (in Each Caplet) (Active ingredients (in each Caplet))

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:26.876627 · Updated: 2026-03-14T23:09:13.832086