Nighttime Sleep Aid

Manufacturer
Meijer Distribution Inc
Effective date
2019-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:55:14

Label at a glance#

ProductNighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

• for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

• take only one dose per day (24 hours)   adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor   children under 12 yrs do not use • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F) • protect from light

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose per day (24 hours)
  1. adults & children 12 yrs & over

2 softgels at bedtime if needed or as directed by a doctor

  1. children under 12 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Vicks® ZzzQuil® LiquiCaps® active ingredient

#1 DOCTOR RECOMMENDED sleep aid active ingredient

nighttime sleep-aid

Diphenhydramine HCl 25 mg

NOT FOR TREATING COLD OR FLU

SEE WARNINGS

For a restful night’s sleep

NON-HABIT FORMING

24 Softgels

actual size

nighttime-sleep-aid-image
nighttime-sleep-aid-image

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-10741250-107-62

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4bd5d4f8-0a36-4cef-b671-10a7b48b40a4e144e496-7326-4397-bfaa-e9cb418766712024-11-05WarningsExact identifier
spl set id: e144e496-7326-4397-bfaa-e9cb41876671

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.