FDA.reportPublic FDA data

Only For

Manufacturer
O4 Global Trading Usa, Llc
Effective date
2019-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:22

Label at a glance#

ProductOnly For SLEEP
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

for relief of occasional sleeplessness

Dosage and administration

take with a full glass of water do not take more than directed  adults and children 12 years of age and over  2 caplets at bedtime if needed, or as directed by a doctor  children under 12 years of age  do not use

Storage and handling

Store at room temperature between 20-25°C (68-77°F) Avoid high humidity • Protect from light

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 25mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses:

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

Warnings:

WARNINGS SECTION

Do not use:

  • in 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:

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

Ask a doctor before use if you
are taking sedatives or tranquilizers

When using this product

  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,
ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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

  • take with a full glass of water
  • do not take more than directed
     adults and children 12 years of age and over 2 caplets at bedtime if needed, or as directed by a doctor
     children under 12 years of age do not use

Other Information:

STORAGE AND HANDLING SECTION

  • Store at room temperature between 20-25°C (68-77°F)
  • Avoid high humidity • Protect from light

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.

Questions Or Comments ?

OTC - QUESTIONS SECTION

1-833-665-9444.

SPL UNCLASSIFIED SECTION

NDC: 73006-111-41

NIGHTTIME SLEEP-AID

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

Tear along perforation push product through foil

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OnlyForOnlyFor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1

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
73006-111-412022-01-28C16284748780-1d6a99b39-d206-a426-e053-dadaa90af4c2Only For- SLEEP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73006-111-41Only ForSLEEP1 in 1 CARTONTABLET11
73006-111-41Only ForSLEEP4 in 1 BLISTER PACKTABLET41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73006-111ONLY FOR SLEEP (DIPHENHYDRAMINE HCL) TABLET [O4 GLOBAL TRADING USA, LLC ]1Legacy NDC, 2 package rows20190430_c4ac8d9f-7bde-4b49-86b0-19a007a934df.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73006-11173006-111-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C BLUE NO. 40KSY80VYS3IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
ISOPROPYL ALCOHOLND2M416302IACT
MAGNESIUM PALMITOSTEARATER4OXA9G5BVIACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TALC7SEV7J4R1UIACT
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
9db406a0-2264-4315-a554-37b5e9387305c4ac8d9f-7bde-4b49-86b0-19a007a934df2019-04-25WarningsExact identifier
spl id: 9db406a0-2264-4315-a554-37b5e9387305
spl set id: c4ac8d9f-7bde-4b49-86b0-19a007a934df

Reported adverse events (FAERS/openFDA)#

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