DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25mg

Manufacturer
DOH CENTRAL PHARMACY
Effective date
2019-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:18

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose itchy nose or throat sneezing itchy, watery eyes

Dosage and administration

adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each capsule)

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes

Warnings

WARNINGS SECTION

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

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

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

    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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
  • children under 12 years: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • store at 15-30 °C (59-86 °F)
  • protect from moisture
  • For 1000 Count: THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image for 53808-1106
25mg

Label Image for 25mg
Label Image for 25mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1

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
53808-1106-12024-01-30C16284748780-11030e365-3da2-111a-e063-dadaa90a10e2DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1106-1Diphenhydramine Hydrochloride30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1106DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190123_94bfe2eb-e860-4cb3-a733-dcabc1305fea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-115-01EA - Each54738-115aa025503-0131-4230-9622-c5356c14939712017-11-06
54738-115-03EA - Each54738-115a1497aeb-1eea-4102-9a9d-26de004a9dcf12017-11-06
54738-115-13EA - Each54738-115aacf6bf3-019c-4e4d-a412-049eb1c8a74712013-06-04

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
53808-110653808-1106-1
54738-115

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals Inc.f184b2aa-91a4-44f9-b688-d4e3181819842024-12-26WarningsExact identifier
ndc (product): 54738-115
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals, Inc.2792032a-ff0f-4d5f-a8e3-b8b8c54f4e992024-12-26WarningsExact identifier
ndc (product): 54738-115
9dac4ba1-0d9e-4c3a-8cde-03cf82072e7f94bfe2eb-e860-4cb3-a733-dcabc1305fea2019-01-22WarningsExact identifier
spl id: 9dac4ba1-0d9e-4c3a-8cde-03cf82072e7f
spl set id: 94bfe2eb-e860-4cb3-a733-dcabc1305fea

Reported adverse events (FAERS/openFDA)#

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