FDA.reportPublic FDA data

diphenhydramine hydrochloride

Manufacturer
RedPharm Drug, Inc.
Effective date
2020-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:03:18

Label at a glance#

Productdiphenhydramine hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose and sneezing • itching of the nose or throat • itchy, watery eyes.

Dosage and administration

DIRECTIONS • Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours. • Children 12 years and under: Consult a Doctor

Storage and handling

Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 L1812 Rev. 11/08

Label contents#

Full prescribing information#

PURPOSE

SPL UNCLASSIFIED SECTION

Antihistamine

USES

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

•
runny nose and sneezing
•
itching of the nose or throat
•
itchy, watery eyes.

WARNINGS

WARNINGS SECTION

Ask a doctor before use if you have

•
a breathing problem such as emphysema or chronic bronchitis
•
glaucoma
•
difficulty in urination due to enlargement of the prostate gland

Do not use with any other product containing diphenhydramine, including products used topically.

Ask a doctor or pharmacist before use if you are

•
taking tranquilizers or sedatives
•
taking other products containing diphenhydramine

When using this product

•
Do not exceed recommended dosage
•
excitability may occur, especially in children
•
marked drowsiness may occur
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
avoid alcoholic drinks
•
use caution when driving a motor vehicle or operating machinery

If pregnant or breastfeeding ask a health professional before use.

KEEP OUT OF THE REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

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

DIRECTIONS

SPL UNCLASSIFIED SECTION

DIRECTIONS

•
Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
•
Children 12 years and under: Consult a Doctor

STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Manufactured for Sandoz Inc.

Princeton, NJ 08540

Manufactured by Epic Pharma, LLC

Laurelton, NY 11413

L1812

Rev. 11/08

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
•
Children 12 years and under: Consult a Doctor

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

KEEP OUT OF THE 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.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

Diphenhydramine Hydrochloride 50 mg

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

67296-087667296-0876

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3

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
67296-0876-12022-01-28C16284748780-1d6a99b39-6ba3-a426-e053-dadaa90af4c242b31ac0-9de1-5763-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0876-1diphenhydramine hydrochloride24 in 1 BOTTLECAPSULE243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0876DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20200121_42b31ac0-9de1-5763-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0648-01EA - Each0185-06486d5a942f-beb8-4cba-9930-fee477bea52f12012-07-24
0185-0648-10EA - Each0185-064848745e0b-9042-4548-9ea1-d7a832626b6f12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-087667296-0876-1
0185-0648

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM LAURYL SULFATE368GB5141JIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT

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
9c9b1dc6-f344-f653-e053-2a95a90a699142b31ac0-9de1-5763-e054-00144ff8d46c2020-01-20WarningsExact identifier
spl id: 9c9b1dc6-f344-f653-e053-2a95a90a6991
spl set id: 42b31ac0-9de1-5763-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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