FDA.reportPublic FDA data

Sleep Aid

Manufacturer
TARGET Corporation
Effective date
2023-11-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:22:43

Label at a glance#

ProductSleep Aid NightTime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

take only one dose per day (24 hours) 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

Use

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

  • in 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 beverages.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose per day (24 hours)
  • 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

OTHER SAFETY INFORMATION

  • each 30 mL contains: sodium 24 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-910-6874

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient in ZzzQuil®*

nighttime sleep aid

diphenhydramine HCI 50 mg

non habit-forming

alcohol free

BERRY FLAVOR

FL OZ (mL)

NOT FOR TREATING COLD OR FLU

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

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.

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2019 Target Brands, Inc.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TARGET Nighttime Sleep Aid
TARGET Nighttime Sleep Aid

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-375SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) LIQUID [TARGET CORPORATION]4Legacy NDC20231102_aa9c8e31-6b80-4457-bb43-0f969f2826f9.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-37511673-375-12, 11673-375-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML · Source PDF

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
c9e6b82f-c816-41c6-aea9-83a4dc900d5faa9c8e31-6b80-4457-bb43-0f969f2826f92023-11-01WarningsExact identifier
spl id: c9e6b82f-c816-41c6-aea9-83a4dc900d5f
spl set id: aa9c8e31-6b80-4457-bb43-0f969f2826f9

Reported adverse events (FAERS/openFDA)#

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