FDA.reportPublic FDA data

Sleep Aid

Manufacturer
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Effective date
2022-09-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:52:55

Label at a glance#

ProductSleep 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

Storage and handling

store at 15-30°C (59°-86°F)

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 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 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

STORAGE AND HANDLING SECTION

  • store at 15-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan

*may contain this ingredient

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Unisom® SleepGels® Active Ingredient**

Maximum Strength

Sleep-Aid Softgels

Diphenhydramine HCI 50 mg

Nighttime sleep-aid

  • Fall asleep fast
  • Sleep soundly
  • Wake up refreshed

Liquid Filled

Safe, Non Habit-Forming

One softgel per dose

SOFTGELS

For Questions or comments or to report an undesired reactionor side effect, please call 1-888-287-1915.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUATE Maximum Strength Sleep-Aid Softgels
EQUATE Maximum Strength Sleep-Aid Softgels

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
49035-93549035-935-32, 49035-935-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT

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
d7d59113-ba37-431c-950a-39ef82307131f1bf058a-b2e4-44d7-99d7-55013e2c692d2022-09-27WarningsExact identifier
spl id: d7d59113-ba37-431c-950a-39ef82307131
spl set id: f1bf058a-b2e4-44d7-99d7-55013e2c692d

Reported adverse events (FAERS/openFDA)#

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