Diphenhydramine Hydrochloride Capsules

Manufacturer
H.J. Harkins Company, Inc.
Effective date
2012-04-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:31:27

Label at a glance#

ProductDiphenhydramine
Active ingredientDiphenhydramine Hydrochloride
Label structure13 sections

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

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 50mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

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.

Warning

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 or pharamcist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking tranquilizers or sedatives.

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.

Pregnancy/breast-feeding warning

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

Keep out of reach of children. 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 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?

OTC - QUESTIONS SECTION

Adverse drug event call: (800) 616-2471

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY4

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-053-06Diphenhydramine06 in 1 BOTTLECAPSULE064
52959-053-10Diphenhydramine10 in 1 BOTTLECAPSULE104
52959-053-12Diphenhydramine12 in 1 BOTTLECAPSULE124
52959-053-15Diphenhydramine15 in 1 BOTTLECAPSULE154
52959-053-20Diphenhydramine20 in 1 BOTTLECAPSULE204
52959-053-30Diphenhydramine30 in 1 BOTTLECAPSULE304
52959-053-52Diphenhydramine52 in 1 BOTTLECAPSULE524

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-053DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]4Legacy NDC, 7 package rows20120419_ea0c7005-3122-4ff4-8bc1-dda8116803c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-053-06EA - Each52959-053bd7cbc32-bb4d-4987-8918-6c4b225934dc12012-07-24
52959-053-10EA - Each52959-053789403f6-7b8d-4855-aad1-137d060ea43012012-07-24
52959-053-12EA - Each52959-053d5ccc5e5-4d97-4bb5-b975-9c04df12a6e612012-07-24
52959-053-15EA - Each52959-053bd9df551-25f6-41fb-90ca-92a1980f6bd512012-07-24
52959-053-20EA - Each52959-053fbc6b446-aa8f-4a9f-b9ac-b30d24a45f8712012-07-24
52959-053-30EA - Each52959-0535b92db91-a9bb-446e-9e10-fed142309ee012012-07-24
52959-053-52EA - Each52959-053ba2f59c3-c1c2-4a57-8dc8-e0d92c14ceac12012-07-24
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 INGREDIENTTC2D6JAD404
DiphenhydramineACTIVE MOIETY8GTS82S83M4
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH484
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA4
GelatinINACTIVE INGREDIENT2G86QN327L4
LactoseINACTIVE INGREDIENTJ2B2A4N98G4
Magnesium StearateINACTIVE INGREDIENT70097M6I304
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU44

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE / ORAL257 mgExact identifier — unii+route+dosage form
LactoseLACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii+route+dosage form
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
GelatinGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route+dosage form
Magnesium StearateMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form

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
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals7f2b72cc-d4f7-431f-be61-c103cf8c489e2026-02-20WarningsExact identifier
ndc (product): 0904-5307
dd6764ad-1dcd-457a-a31a-5fb041c83a7fea0c7005-3122-4ff4-8bc1-dda8116803c12012-04-18WarningsExact identifier
spl id: dd6764ad-1dcd-457a-a31a-5fb041c83a7f
spl set id: ea0c7005-3122-4ff4-8bc1-dda8116803c1

Reported adverse events (FAERS/openFDA)#

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