FDA.reportPublic FDA data

Sleep-EZ Nighttime Sleep Aid

Manufacturer
Safrel Pharmaceuticals, LLC.
Effective date
2021-05-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:40:47

Label at a glance#

ProductSleep-EZ Nighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

provides relief of occasional sleeplessness

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years of age and over: - take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

provides relief of occasional sleeplessness

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
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

  • heart disease

Ask a 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
  • excitability may occur, especially in children
  • 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 children.

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 signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: - take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years of age: do not use

Other Information

OTHER SAFETY INFORMATION

  • Each caplet contains: Calcium 23.52 mg
  • store at 25°C (77°F); excursions permitted between 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

Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Tylenol® Simply Sleep active ingredients*

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.

Diphenhydramine HCl Tablets, 25 mg

Sleep AidSleep Aid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71309-110-022023-01-30C16284748780-1f386c64a-12b1-0266-e053-dadaa90a7c1aSleep-EZ Nighttime Sleep Aid
71309-110-102023-01-30C16284748780-1f386c64a-12b1-0266-e053-dadaa90a7c1aSleep-EZ Nighttime Sleep Aid
71309-110-252023-01-30C16284748780-1f386c64a-12b1-0266-e053-dadaa90a7c1aSleep-EZ Nighttime Sleep Aid
71309-110-502023-01-30C16284748780-1f386c64a-12b1-0266-e053-dadaa90a7c1aSleep-EZ Nighttime Sleep Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-110-01Sleep-EZ Nighttime Sleep Aid1000 in 1 BOTTLETABLET, COATED10003
71309-110-02Sleep-EZ Nighttime Sleep Aid2 in 1 POUCHTABLET, COATED23
71309-110-05Sleep-EZ Nighttime Sleep Aid500 in 1 BOTTLETABLET, COATED5003
71309-110-10Sleep-EZ Nighttime Sleep Aid100 in 1 BOTTLETABLET, COATED1003
71309-110-25Sleep-EZ Nighttime Sleep Aid25 in 1 BOXTABLET, COATED253
71309-110-25Sleep-EZ Nighttime Sleep Aid2 in 1 POUCHTABLET, COATED23
71309-110-30Sleep-EZ Nighttime Sleep Aid30 in 1 BOTTLETABLET, COATED303
71309-110-30Sleep-EZ Nighttime Sleep Aid1 in 1 CARTONTABLET, COATED13
71309-110-50Sleep-EZ Nighttime Sleep Aid50 in 1 BOXTABLET, COATED503
71309-110-50Sleep-EZ Nighttime Sleep Aid2 in 1 POUCHTABLET, COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-110SLEEP-EZ NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET, COATED [SAFREL PHARMACEUTICALS, LLC.]3Legacy NDC, 10 package rows20210613_87537ba2-f4d7-8ea3-e053-2a95a90acc38.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
71309-11071309-110-25, 71309-110-50, 71309-110-02, 71309-110-30, 71309-110-05, 71309-110-01, 71309-110-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYVINYL ALCOHOL532B59J990IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT

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
c3a6790e-f944-66f0-e053-2a95a90a981287537ba2-f4d7-8ea3-e053-2a95a90acc382021-05-31WarningsExact identifier
spl id: c3a6790e-f944-66f0-e053-2a95a90a9812
spl set id: 87537ba2-f4d7-8ea3-e053-2a95a90acc38

Reported adverse events (FAERS/openFDA)#

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