Sleep Aid

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2020-07-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:19:51

Label at a glance#

ProductSleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

for 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

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hcl 25mg

Purpose

OTC - PURPOSE SECTION

Sleep-aid

Uses:

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

Warnings:

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

Ask Doctor:

OTC - ASK DOCTOR SECTION

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 DOCTOR/PHARMACIST:

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

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

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

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: 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 15 mg
store between 20°-25°C (68°-77°F); avoid high humidity
protect from light
read all product information before using

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, opadry II

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.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
72090-020-242022-01-28C16284748780-1d6a99b39-75e6-a426-e053-dadaa90af4c2a9637ec7-9a71-4023-e053-2995a90ad0da

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-020-24Sleep Aid24 in 1 BOTTLETABLET242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-020SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]2Current NDC, Legacy NDC, 1 package rows20200702_a9637ec7-9a71-4023-e053-2995a90ad0da.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
72090-02072090-020-24

Ingredients#

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

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa9678fed-bda5-9513-e053-2995a90a25a12025-12-29WarningsExact identifier
ndc (product): 72090-020
a965f02e-e424-595e-e053-2995a90ab710a9637ec7-9a71-4023-e053-2995a90ad0da2020-07-01WarningsExact identifier
spl id: a965f02e-e424-595e-e053-2995a90ab710
spl set id: a9637ec7-9a71-4023-e053-2995a90ad0da

Reported adverse events (FAERS/openFDA)#

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