Nighttime Sleep-aid

Nighttime Sleep-aid
SPL v2
SPL
SPL Set ID dac0ec69-4c8f-4455-a26a-37dbe19ffd00
Route
ORAL
Published
Effective Date 2020-01-02
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

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-07-26
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.

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 y ou are taking sedatives or tranquilizers or any other sleep aid

Section 53414-9

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

Directions
  • take only one dose per day (24 hours) - see Overdose warning

adults & children 12 years & over

          ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Other Information
  • store at 15°-30° C (59°-86° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • protect from light
Overdose Warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

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

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Nighttime Sleep-Aid 48 SOFTGELS

NDC 51013-167-13

*Compare to the active ingredient in Vicks® ZzzQuil® LiquiCaps®

When Using This Product
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

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

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.

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 y ou are taking sedatives or tranquilizers or any other sleep aid

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) - see Overdose warning

adults & children 12 years & over

          ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Other Information (Other information)
  • store at 15°-30° C (59°-86° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • protect from light
Overdose Warning: (Overdose warning:)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, 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 48 SOFTGELS

NDC 51013-167-13

*Compare to the active ingredient in Vicks® ZzzQuil® LiquiCaps®

When Using This Product (When using this product)
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
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 asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:00.336948 · Updated: 2026-03-14T22:55:49.080281