FDA.reportPublic FDA data

Nighttime Sleep Aid

Manufacturer
We Care Distributor Inc | Elysium Pharmaceutical Ltd.
Effective date
2016-02-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:45:08

Label at a glance#

ProductNighttime 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 adults and children 12 years of age and over - take 2 tablets 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 tablet)

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

  • with any other products containing diphenhydramine, even one used on skin

  • in children under 12 years of age

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

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

  • drowsiness may occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operating a 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

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

  • each caplet contains; calcium 25 mg

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • avoid excessive heat and humidity

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image 25image 25

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

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
70005-014-022020-01-31C16284748780-19d75b9d0-8b2d-f424-e053-dadaa90a57ceDrug Facts
70005-014-252020-01-31C16284748780-19d75b9d0-8b2d-f424-e053-dadaa90a57ceDrug Facts
70005-014-502020-01-31C16284748780-19d75b9d0-8b2d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-014-02Nighttime Sleep Aid2 in 1 POUCHTABLET22
70005-014-02Nighttime Sleep Aid2 in 1 BOXTABLET22
70005-014-25Nighttime Sleep Aid25 in 1 BOXTABLET252
70005-014-25Nighttime Sleep Aid4 in 1 POUCHTABLET42
70005-014-50Nighttime Sleep Aid4 in 1 POUCHTABLET42
70005-014-50Nighttime Sleep Aid50 in 1 BOXTABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-014NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WE CARE DISTRIBUTOR INC]2Legacy NDC, 6 package rows20160224_27f90f09-7cd5-4d54-b1bf-4e47ca632ac4.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
70005-01470005-014-25, 70005-014-50, 70005-014-02

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYVINYL ALCOHOL532B59J990IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TALC7SEV7J4R1UIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT

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
75aaf9f0-4abc-4321-9e6f-0838c362f79427f90f09-7cd5-4d54-b1bf-4e47ca632ac42016-02-23WarningsExact identifier
spl id: 75aaf9f0-4abc-4321-9e6f-0838c362f794
spl set id: 27f90f09-7cd5-4d54-b1bf-4e47ca632ac4

Reported adverse events (FAERS/openFDA)#

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