Sleep Aid

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:29:23

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 and over: take 2 caplets at bedtime if needed or as directed by doctor ■ children under 12 years: do not use

Label contents#

Full prescribing information#

Active Ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Night Time 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.

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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are:■taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product:

■ avoid alcoholic drinks
■ drowsiness will occur 

■ do not drive a motorvehicle or operate machinery.

OTC - STOP USE SECTION

Stop use and ask a doctor if:

■ sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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: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(See overdose warning) 

■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor

■ children under 12 years: do not use

OTHER INFORMATION

OTHER SAFETY INFORMATION

■each caplet contains: calcium 23.52 mg

■store between 15-30°C (59-86°F).

■Avoid high humidity.

■ Protect from light.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call toll free 1-732-698-5070 Mon to Fri 9am – 5pm.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleep-Aid-Regular Strength-100ctSleep-Aid-Regular Strength-100ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN6
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD6

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
72090-020-102023-10-25C16284748780-1d6a99b39-8fd3-a426-e053-dadaa90af4c2Nighttime Sleep Aid
72090-020-102022-01-28C16284748780-1d6a99b39-8fd3-a426-e053-dadaa90af4c2Nighttime Sleep Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-020-10Sleep Aid100 in 1 BOTTLETABLET1006

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
72090-02072090-020-10

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 · 1 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 (package): 72090-020-10
ndc (product): 72090-020
ndc11 (package): 72090002010
spl id: 29ee011c-3b29-40a2-8b9b-ff1f5cb2fb69
spl set id: a9678fed-bda5-9513-e053-2995a90a25a1

Reported adverse events (FAERS/openFDA)#

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