FDA.reportPublic FDA data

Nighttime Sleep-Aid

Manufacturer
VALU MERCHANDISERS COMPANY | Bionpharma Inc. | Patheon Softgels Inc
Effective date
2023-10-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:40

Label at a glance#

ProductNighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor. swallow whole; do not crush, chew, or dissolve

Storage and handling

store at 20 o C to 25 o C (68 o F to 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F). protect from light

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

  • for children under 12 years of age
  • with any product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuosly for more than 2 weeks, consult your doctor.

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 Centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor.
  • swallow whole; do not crush, chew, or dissolve

Other information

STORAGE AND HANDLING SECTION

  • store at 20 oC to 25 oC (68 oF to 77 oF)
  • avoid high humidity and excessive heat above 40 oC (104 oF).
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain truglycerides, polyethylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-235-2466 (Mon-Fri 9AM-5PM EST)

SPL UNCLASSIFIED SECTION

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Made in USA using domestic and imported materials.

*This product is not manufacturerd or distributed by the owners of Unisom® SleepGels®.

PROUDLY DISTRIBUTED BY: ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

For product information please visit: bestchoicebrand.com/66729

R0523

L0000720

60's carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best

Choice®

*Compare to the

active ingredient in

Unisom®

SleepGels®

MAXIMUM STRENGTH

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCL

CAPSULES 50 mg

Fall asleep fast

Sleep soundly

Safe, non habit-forming

One softgel per dose

60

SOFTGELS**

**LIQUID-FILLED CAPSULES

image001image001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD2
1020477diphenhydramine HCl 50 MG Oral CapsuleSY2

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
63941-683-17Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED12
63941-683-17Nighttime Sleep-Aid60 in 1 BOTTLECAPSULE, LIQUID FILLED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-683NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [VALU MERCHANDISERS COMPANY]2Current NDC, 2 package rows20231013_fed2f7ae-2829-f967-e053-6294a90adc0a.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63941-68363941-683-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN6O92ICV9RUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 HCLVALU MERCHANDISERS COMPANYfed2f7ae-2829-f967-e053-6294a90adc0a2023-10-12WarningsExact identifier
ndc (package): 63941-683-17
ndc (product): 63941-683
ndc11 (package): 63941068317
spl id: 0788c3b6-d878-b337-e063-6294a90acd3a
spl set id: fed2f7ae-2829-f967-e053-6294a90adc0a

Reported adverse events (FAERS/openFDA)#

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