Diphendydramine Hydrochloride Capsules

Manufacturer
Contract Pharmacy Services-PA
Effective date
2010-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:28

Label at a glance#

ProductDIPHENDYDRAMINE HYDROCHLORIDE
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

Dosage and administration

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours. Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours. Children under 6 years of age: ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH CAPSULE)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg & 50 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USES

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

WARNINGS

WARNINGS SECTION

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking taking tranquilizers or sedative.

When using this product

OTC - WHEN USING SECTION

you may get drowsy; avoid alcoholic drinks. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery. Excitability may occur, especially in children. Do not use any other products containing diphenhydramine.

If pregnant or breast-feeding,

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

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222

DIRECTIONS

SPL UNCLASSIFIED SECTION

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours.

Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 6 years of age: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Store at controlled room temperature 59-86 degrees F.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose, starch, gelatin with bisulfites and artificial colors.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

call toll free 734-743-6000

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--08/2010--NJW

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25 mg Capsules
25 mg Capsules

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mg Capsules
50 mg Capsules

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1

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
67046-125-302019-10-21C16284748780-1956f9ecf-d42e-621f-e053-dbdaa90a74adDiphendydramine Hydrochloride Capsules
67046-126-302019-10-21C16284748780-1956f9ecf-d42e-621f-e053-dbdaa90a74adDiphendydramine Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-125-30DIPHENDYDRAMINE HYDROCHLORIDE30 in 1 BLISTER PACKCAPSULE301
67046-126-30DIPHENDYDRAMINE HYDROCHLORIDE30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-125DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100809_1d026ead-c3de-4dc6-9d3c-5a603f6dde4e.zip
67046-126DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100809_1d026ead-c3de-4dc6-9d3c-5a603f6dde4e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5306-24EA - Each0904-5306b0edee36-ed2f-4648-b6e0-36b1ba93f7e612019-05-02
0904-5306-60EA - Each0904-5306555c059d-810d-4ef2-9c17-83fdd1a60d9012013-02-11
0904-5306-61EA - Each0904-530679119dfd-637d-4b1f-a12c-6fcdcad2133212012-07-24
0904-5306-80EA - Each0904-53060b4a65cc-9c47-45af-bead-889c34a7981412013-02-11
0904-5307-60EA - Each0904-5307fbc100c3-1d2e-4360-bd2f-a92b1e556d3b12013-02-11
0904-5307-80EA - Each0904-5307602b6862-e0e7-4d9b-bcb4-48a7a3eba31612013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67046-12567046-125-30
0904-5306
67046-12667046-126-30
0904-5307

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 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 HYDROCHLORIDEMajor Pharmaceuticals04e70311-6412-4a20-84e3-f6e26d5f19ab2026-02-20WarningsExact identifier
ndc (product): 0904-5306
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals7f2b72cc-d4f7-431f-be61-c103cf8c489e2026-02-20WarningsExact identifier
ndc (product): 0904-5307
1d026ead-c3de-4dc6-9d3c-5a603f6dde4e1d026ead-c3de-4dc6-9d3c-5a603f6dde4e2010-07-30WarningsExact identifier
spl id: 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e
spl set id: 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e

Reported adverse events (FAERS/openFDA)#

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