Sleep Aid

Manufacturer
Walgreens
Effective date
2022-09-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:53:14

Label at a glance#

ProductSleep Aid Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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.

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

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 a 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 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol, sorbitan

*may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Unisom® SleepGels® active ingredient††

NIGHTTIME SLEEP AID

DIPHENHYDRAMINE HCl, 50 mg

NIGHTTIME SLEEP AID

NIGHTTIME

MAXIMUM STRENGTH

SOFTGELS

  • Fall asleep fast

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

ONE LIQUID-FILLED SOFTGEL PER DOSE

**This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®. 

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALGREENS Nighttime Sleep-Aid
WALGREENS Nighttime Sleep-Aid

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0935-16EA - Each0363-09358451b451-45f0-4389-8277-4dacd7da7f5e12022-06-06
0363-0935-32EA - Each0363-09350633d64f-618c-4007-a9b5-d1478e6e33aa12022-06-06
0363-0935-60EA - Each0363-093572e166a0-e1d2-472d-aacf-ef0196d2b7ad12022-06-06

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
0363-09350363-0935-32, 0363-0935-60, 0363-0935-16

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
05b2674a-4726-44a3-a18c-0795562952236ee6fefb-cafc-4cb6-8f2e-df9e4171b8fc2023-01-18WarningsExact identifier
spl set id: 6ee6fefb-cafc-4cb6-8f2e-df9e4171b8fc

Reported adverse events (FAERS/openFDA)#

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