Diphenhydramine Hydrochloride

Manufacturer
Pharmacy Value Alliance, LLC
Effective date
2021-01-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:35

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep.

Dosage and administration

take only one dose per day (24 hours) see Overdose warning adults & children 12 years and over 2 gelcaps at bedtime if needed or as directed by a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each gelcap)

Diphenhydramine HCl USP, 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

■ for relief of occasional sleeplessness

■ reduces time to fall asleep if you have difficulty falling asleep.

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 asthma, emphysema, or chronic bronchitis

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

■ heart disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking sedatives or tranquilizers or any other sleep-aid

When using this product

OTC - WHEN USING SECTION

■ avoid alcoholic beverages and other drugs that cause drowsiness

■ drowsiness will occur

■ 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 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

Keep out of reach of children.

Overdose Warning:

OVERDOSAGE SECTION

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take only one dose per day (24 hours) see Overdose warning

adults & children 12 years and over

2 gelcaps at bedtime if needed or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.

■ avoid high humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red # 28, D&C red # 33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6 gelatin, hydroxyl propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

48 count48 count

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
68016-789-482024-01-30C16284748780-11030e365-14ee-111a-e063-dadaa90a10e2Sleep-Aid Diphenhydramine HCl USP, 25 mg NIGHTTIME SLEEP AID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-789-48Diphenhydramine Hydrochloride48 in 1 BOTTLETABLET483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-789DIPHENHYDRAMINE HYDROCHLORIDE TABLET [PHARMACY VALUE ALLIANCE, LLC]3Legacy NDC, 1 package rows20210131_6bca78f3-6836-9a71-e053-2a91aa0ac3d6.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-78968016-789-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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
ba16b4eb-30dd-a8df-e053-2995a90af7f66bca78f3-6836-9a71-e053-2a91aa0ac3d62021-01-29WarningsExact identifier
spl id: ba16b4eb-30dd-a8df-e053-2995a90af7f6
spl set id: 6bca78f3-6836-9a71-e053-2a91aa0ac3d6

Reported adverse events (FAERS/openFDA)#

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