FDA.reportPublic FDA data

Sleep Aid

Manufacturer
Family Dollar (FAMILY WELLNESS)
Effective date
2021-10-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:31:27

Label at a glance#

ProductSleep Aid NightTime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

For relief of occasional sleeplessness

Dosage and administration

take only one dose (2 caplets) per day (24 hours) adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

For relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis 

  • trouble urinating due to an enlarged prostate gland

  • glaucoma

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 of 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 (2 caplets) per day (24 hours)
  • adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
  • children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • each caplet contains: calcium 25 mg
  • store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

*contains one or more of these ingredients

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 THE ACTIVE INGREDIENT IN TYLENOL® SIMPLY SLEEP®†

NIGHTTIME

Sleep-Aid

Diphenhydramine HCI, 25 mg / Nighttime sleep aid

  • Safe, Non Habit-Forming
  • Does not Contain Pain Reliever
  • Fall Asleep Fast & Wake Up Rested

CAPLETS

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Simply Sleep®.

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: MIDWOOD BRANDS, LLC

10611 MONROE RD., MATTHEWS, NC 28105

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS Nighttime Sleep-Aid
FAMILY WELLNESS Nighttime Sleep-Aid

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-80055319-800-01, 55319-800-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
f4182753-5350-4bf3-a3e5-78805f28c4ffc448cace-28ce-4556-a077-ee507f116fd52021-10-20WarningsExact identifier
spl id: f4182753-5350-4bf3-a3e5-78805f28c4ff
spl set id: c448cace-28ce-4556-a077-ee507f116fd5

Reported adverse events (FAERS/openFDA)#

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