FDA.reportPublic FDA data

nighttime sleep aid

Manufacturer
CVS Pharmacy
Effective date
2019-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:00:33

Label at a glance#

Productnighttime sleep aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

• adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

  • for relief of occasional sleeplessness

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
  • trouble urinating due to an enlarged 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 drinks

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

  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible dye-free ink*, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE SIZE 60 SOFTGELS

Compare to the active ingredient in Unisom® SleepGels®

SoftGels

Nighttime Sleep-Aid

DIPHENHYDRAMINE HCl 50 mg

Free of artificial dyes & preservatives

Non-habit forming

One softgel per dose

60 SOFTGELS

Actual Bottle Size on Top Panel

Actual Size

6n6-17-nighttime sleep aid-1.jpg
6n6-17-nighttime sleep aid-1.jpg
6n6-17-nighttime sleep aid-2.jpg
6n6-17-nighttime sleep aid-2.jpg

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-43969842-439-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT

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
343180d0-b7ba-4559-b580-42f6e412f984d5b063d6-a6b1-4e42-a278-61f65e7fa3762020-10-26WarningsExact identifier
spl set id: d5b063d6-a6b1-4e42-a278-61f65e7fa376

Reported adverse events (FAERS/openFDA)#

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