DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 50mg

Manufacturer
Richmond Pharmaceuticals, Inc. | Advance Pharmaceutical Inc.
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:49

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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 capsule 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 50 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 capsule 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

Questions or Comments

OTC - QUESTIONS SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 50 MG

ANTIHISTAMINE

NDC: 54738-116-01– 100 COUNT

IMG_4682IMG_4682

NDC: 54738-116-03– 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD2
1020477diphenhydramine HCl 50 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130054738116014GTIN-13: 0054738116014
EAN-13: 0054738116014
GTIN-12: 054738116014
UPC-A: 054738116014
GTIN storage (14 digits): 00054738116014
IMG_4682.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-116-01Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1002
54738-116-03Diphenhydramine Hydrochloride1000 in 1 BOTTLECAPSULE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-116DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20171030_ab67121e-2477-47dd-a7ec-114453df3fd4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-116-01EA - Each54738-116de51d6f9-9d96-4ca6-a402-797d803b061f12017-11-06
54738-116-03EA - Each54738-1162375fe3e-94f9-4410-ba4b-38af72221de312017-11-06
54738-116-13EA - Each54738-116f14c9574-5961-47ef-b3d1-da2fac68a61a12013-06-04

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
54738-11654738-116-01, 54738-116-03

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 · Source PDF

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
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals Inc.f184b2aa-91a4-44f9-b688-d4e3181819842024-12-26WarningsExact identifier
ndc (product): 54738-116
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals, Inc.ab67121e-2477-47dd-a7ec-114453df3fd42017-10-30WarningsExact identifier
ndc (package): 54738-116-03
ndc (package): 54738-116-01
ndc (product): 54738-116
ndc11 (package): 54738011601
ndc11 (package): 54738011603
spl id: 5cc3bf1b-466c-6a53-e053-2a91aa0abfa6
spl set id: ab67121e-2477-47dd-a7ec-114453df3fd4

Reported adverse events (FAERS/openFDA)#

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