FDA.reportPublic FDA data

Nighttime Sleep-Aid

Manufacturer
Guardian Drug Company
Effective date
2024-01-11
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:07

Label at a glance#

ProductNighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 sections

Dosage and administration

take only one dose per day (24 hours) - see Overdose warning only use dosage cup that is included with this product for accurate dosing mL = millilitere; Tbsp = teblespoons Age  Dose   adults & chlidren 12 year & over  one = 30 mL (2Tbsp) at bedtime if needed or as directed by a doctor  childrens under 12 years  do not use

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

PURPOSE

OTC - PURPOSE SECTION

Nighttime sleep-aid

USE(S)

INDICATIONS & USAGE SECTION

  • for relief of occasional sleeplessness
  • helps you to fall asleep if you have difficulty falling asleep

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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

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

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

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

sleepleness persists continuously for more than two 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

OVERDOSAGE SECTION

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
  • only use dosage cup that is included with this product for accurate dosing
  • mL = millilitere; Tbsp = teblespoons


Age 
Dose 
 adults & chlidren 12 year & over one = 30 mL (2Tbsp) at bedtime if needed or as directed by a doctor
 childrens under 12 years do not use

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • each 30 mL (2 Tbsp) contain: sodium 30 mg
  • store at room temperature
  • protect from light

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

citric acid, FD&C Blue # 1, FD&C Red # 40, flavors, high fructose corn syrup, polyoxyl 40 stearate, purified water, saccharine sodium, sodium benzoate, sodium citrate.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53041-633-58

*Compare to the active ingredient in ZZZQUIL® Nighttime Sleep-Aid


Nighttime Sleep-Aid

Warming Berry Flavor

Relieves:

Occasional Sleeplessness


6 FL OZ (177 ML)


gdc-633-6ozgdc-633-6oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN1
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD1
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY1
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-633-58Nighttime Sleep-Aid177 mL in 1 BOTTLELIQUID1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-633NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) LIQUID [GUARDIAN DRUG COMPANY]1Current NDC, 1 package rows20240113_329d343f-2056-4870-930c-348917bfb2bc.zip

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
53041-63353041-633-58

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
Nighttime Sleep-AidDIPHENHYDRAMINE HCLGuardian Drug Company329d343f-2056-4870-930c-348917bfb2bc2024-01-11WarningsExact identifier
ndc (package): 53041-633-58
ndc (product): 53041-633
ndc11 (package): 53041063358
spl id: 329d343f-2056-4870-930c-348917bfb2bc
spl set id: 329d343f-2056-4870-930c-348917bfb2bc

Reported adverse events (FAERS/openFDA)#

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