FDA.reportPublic FDA data

Maximum Strength Nighttime Sleep-Aid

Manufacturer
Healthlife of USA | Elysium Pharmaceuticals Limited
Effective date
2017-10-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:11:29

Label at a glance#

ProductMaximum Strength Nighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

Relief of occasional sleeplessness

Dosage and administration

Do not take more than directed (see overdosage warning)  Adults and children 12 years and over:  Take 1 softgel at bedtime if needed or as directed by a doctor Children under 12 years of age:  Do not use

Label contents#

Full prescribing information#

Drug Facts 

OTC - ACTIVE INGREDIENT SECTION

Maximum Strength Nighttime Sleep-Aid

Purpose

OTC - PURPOSE SECTION

Nighttime Sleep-Aid

Active Ingredient (in each softgel) 

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 50mg 

Uses

INDICATIONS & USAGE SECTION

  • Relief of occasional sleeplessness

Warnins 

WARNINGS SECTION

Do not use

  • 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 antihistamine and nighttime cold/flu products

Ask a doctor before use if you have 

OTC - ASK DOCTOR SECTION

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

Ask your doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedative or tranquilizers or any other sleep-aid.

When using this product

OTC - WHEN USING SECTION

  • drowsiness will occur
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery 

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 childern. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any sighs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not take more than directed (see overdosage warning) 
  • Adults and children 12 years and over: Take 1 softgel at bedtime if needed or as directed by a doctor
  • Children under 12 years of age: Do not use

Other Information

OTC - WHEN USING SECTION

  • Store at 15°-30°C (59°-86°F)
  • Read all product information before using 
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • FD&C Blue#1
  • Gelatin
  • Glycerin
  • Polyethylene glycol
  • Polyvinyl acetate phthalate
  • Polyvinyl glycol
  • Sorbitol
  • Titanium Dioxide
  • Water

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST or www.healthlifeofusa.com

Maximum Strength Nighttime Sleep-AidDiphenhydramine HCL 50mg / Nighttime Sleep-Aid 16  Softgels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

afe & Non-Habit Forming
Get to sleep Fast
Sleep Soundly
Wake Refreshed

Compare to Unisom® Sleepgels® active ingredients

Max.Strength Nighttime Sleep-AidMax.Strength Nighttime Sleep-Aid

Distributed by:

Healthlife of USA LLC
Rahway
NJ 07065
www.healthlifeofusa.com

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeITF963753max.strength nighttime sleep-aid.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-117-162024-10-18C16284748780-19d75b9d0-33d6-f424-e053-dadaa90a57ceMaximum Strength Nighttime Sleep-Aid
69517-117-162020-01-31C16284748780-19d75b9d0-33d6-f424-e053-dadaa90a57ceMaximum Strength Nighttime Sleep-Aid

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
69517-11769517-117-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT

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
085afb0e-7401-114f-e063-6394a90a7fb905f9c148-22fc-484e-b02a-59c4812b94242024-10-18WarningsExact identifier
spl set id: 05f9c148-22fc-484e-b02a-59c4812b9424

Reported adverse events (FAERS/openFDA)#

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