berkley and jensen sleep aid

Manufacturer
BJWC
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:26:27

Label at a glance#

Productberkley and jensen sleep aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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) • only use the dose cup provided adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor children under 12 yrs do not use

Storage and handling

• each 30 mL contains: sodium 20 mg • store at 20-25 ° C (68-77 ° F)

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

  • for 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
  • difficulty in urination due to enlargement of the 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 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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose per day (24 hours)
  • only use the dose cup provided

adults & children 12 yrs & over

30 mL at bed time if needed or as directed by a doctor

children under 12 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 20 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-BJS-CLUB

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient in Vicks® ZzzQuil®

berkley jensen®

Compare to the Active Ingredient in Vicks® ZzzQuil®

berkley jensen®

SLEEP-AID

DIPHENHYDRAMINE HCl 50 mg PER 30 mL

NIGHTTIME SLEEP-AID

NON-HABIT FORMING

NOT FOR TREATING COLD OR FLU

10% ALCOHOL

NIGHTTIME SLEEP-AID

SLEEP-AID

DIPHENHYDRAMINE HCl 50 mg PER 30 mL

HELPS YOU FALL ASLEEP • NON-HABIT FORMING

100% MONEY-BACK GUARANTEE

BERRY FLAVOR

THREE 12 FL OZ (355mL) BOTTLES, TOTAL 36 FL OZ (2.25 pt) 1.06L

sleep-aid-image-1
sleep-aid-image-1
sleep-aid-image-2
sleep-aid-image-2

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-186-40berkley and jensen sleep aid3 in 1 CARTONSOLUTION33
68391-186-40berkley and jensen sleep aid355 mL in 1 BOTTLESOLUTION3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-186BERKLEY AND JENSEN SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [BJWC]3Current NDC, Legacy NDC, 2 package rows20241018_e31917a1-e72d-4f71-893f-43046169a32d.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
68391-18668391-186-40

Ingredients#

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

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

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
berkley and jensen sleep aidDIPHENHYDRAMINE HCLBJWCe31917a1-e72d-4f71-893f-43046169a32d2024-10-16WarningsExact identifier
ndc (package): 68391-186-40
ndc (product): 68391-186
ndc11 (package): 68391018640
spl id: d63782ee-785f-4bab-bc05-52b4b8d8fca3
spl set id: e31917a1-e72d-4f71-893f-43046169a32d

Reported adverse events (FAERS/openFDA)#

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