FDA.reportPublic FDA data

Nighttime Sleep Aid

Manufacturer
Allegiant Health
Effective date
2024-01-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:14:17

Label at a glance#

ProductNighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

take only as recommended use dosage cup or tablespoon Age                                    Dose Adults & children 12 years & over: One Dose = 2 tablespoons (30 mL) at bed time if needed or as directed by a doctor   Children under 12 yrs:    Do not use

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50mg

In each 30mL dose cup or 2 tablespoons

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • Do not use n for children under 12 years of age.
  • with any other product containing diphenhydramine, even one used on skin
  • with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • heart disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking sedatives or tranquilizers or any other sleep aid

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  •  avoid alcoholic beverages and other drugs that cause drowsiness
  •  drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

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 breastfeeding,

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as recommended
  • use dosage cup or tablespoon

Age                                   Dose
Adults & children

12 years & over: One Dose = 2 tablespoons (30 mL) at bed time if needed or as directed by a doctor

 
Children under 12 yrs:   Do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • dosage cup provided
  • store at room temperature
  • do not use if imprinted shrink band is missing or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup,
poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium
citrate, sodium saccharin

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM to 5PM

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nighttime Sleep Aid
Nighttime Sleep Aid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN3
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD3
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY3
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY3

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
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
69168-446-39Nighttime Sleep Aid354 mL in 1 BOTTLELIQUID3543

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-44669168-446-39

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLOXAMER 407TUF2IVW3M2IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARINFST467XS7DIACT

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 AidNIGHTTIME SLEEP AIDAllegiant Health88feea1d-c961-45e9-b9a6-1418b970aaba2024-01-16WarningsExact identifier
ndc (package): 69168-446-39
ndc (product): 69168-446
ndc11 (package): 69168044639
spl id: 88fee002-990d-4311-a3a6-2f8ed1fb6579
spl set id: 88feea1d-c961-45e9-b9a6-1418b970aaba

Reported adverse events (FAERS/openFDA)#

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