FDA.reportPublic FDA data

Sleep Aid

Manufacturer
WinCo Foods, LLC
Effective date
2024-05-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:03:49

Label at a glance#

ProductSleep Aid NightTime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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) - (see overdose warning) mL= milliliter keep dosing cup with product measure only with dosing cup provided do not use any other dosing device adults and children 12 years and over one dose=30 mL at bedtime if needed, or as directed by a doctor children under 12 years do not use 

Label contents#

Full prescribing information#

Active ingredient (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 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

  • with any other product containing diphenhydramine, even one used on the skin
  • for children under 12 years of age
  • with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as asthma, emphysema, or chronic bronchitis 
  • glaucoma
  • heart disease
  • 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 or any other sleep-aid.

When using this product

OTC - WHEN USING SECTION

  • drowsiness will occur
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • be careful when driving a motor vehicle or operating machinery

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

Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose per day (24 hours) - (see overdose warning)
  • mL= milliliter
  • keep dosing cup with product
  • measure only with dosing cup provided do not use any other dosing device
  • adults and children 12 years and over
    • one dose=30 mL at bedtime if needed, or as directed by a doctor
  • children under 12 years do not use 

Other information

SPL UNCLASSIFIED SECTION

  • each 30 mL contains: sodium 23 mg
  • store at 20-25ºC (68-77ºF)
  • do not refrigerate
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate

Questions?

OTC - QUESTIONS SECTION

Or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4PM  MST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active igredient in ZZZQUIL®

NIGHTTIME

Sleep Aid

DIPHENHYDRAMINE HCI 50 mg / NIGHTTIME SLEEP-AID

Not For Treating Cold or Flu

Safe, Non-Habit Forming

Alcohol 10%

Berry Flavor

FL OZ (mL)

FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES

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

*This product is not manufactured or distributed byThe Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

www.wincofoods.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Winco Foods NightTime Sleep-Aid Berry Flavor
Winco Foods NightTime Sleep-Aid Berry Flavor

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-290SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) LIQUID [WINCO FOODS, LLC]4Legacy NDC20240504_2eb8da09-e6d6-467a-8fb8-fdf8a6738dad.zip

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
67091-29067091-290-17

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MIACT
FD&C RED NO. 40WZB9127XOAIACT

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
69901aa9-864a-421b-95b2-0cb2c5af96ca2eb8da09-e6d6-467a-8fb8-fdf8a6738dad2026-04-06WarningsExact identifier
spl set id: 2eb8da09-e6d6-467a-8fb8-fdf8a6738dad

Reported adverse events (FAERS/openFDA)#

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