Diphenhydramine Hydrochloride

Manufacturer
CVS Pharmacy, Inc
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:13

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat  temporarily relieves these symptoms due to the common cold:  runny nose  sneezing

Dosage and administration

 take every 4 to 6 hours, or as directed by a doctor  do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each banded capsule)

Diphenhydramine HCI 25 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat
 temporarily relieves these symptoms due to the common cold:  runny nose  sneezing

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

 to make a child sleepy

 with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

 a breathing problem such as emphysema or chronic bronchitis

 glaucoma

 trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

 marked drowsiness may occur

 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

DIrections

DOSAGE & ADMINISTRATION SECTION

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children 12 years of age and over1 to 2 capsules
children 6 to under 12 years of age1 capsule
children under 6 years of agedo not use this product in
children under 6 years of age

Other information

OTHER SAFETY INFORMATION

 store in a dry place at 15° – 30°C (59° – 86°F)
 protect from moisture

INACTIVE INGREDIENT SECTION

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

OTC - QUESTIONS SECTION

Questions or comments? 1-800-231-4670

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-34601

Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Benadryl®*

Allergy Relief

DIPHENHYDRAMINE HYDROCHLORIDE
25 mg - Antihistamine

Relief of: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat

100 CAPSULES

CVS LabelCVS Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-835-01Diphenhydramine Hydrochloride1 in 1 CARTONCAPSULE12
51316-835-01Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1002
51316-835-03Diphenhydramine Hydrochloride4 in 1 CARTONCAPSULE42
51316-835-03Diphenhydramine Hydrochloride12 in 1 BLISTER PACKCAPSULE122
51316-835-07Diphenhydramine Hydrochloride365 in 1 BOTTLECAPSULE3652
51316-835-08Diphenhydramine Hydrochloride2 in 1 CARTONCAPSULE22
51316-835-08Diphenhydramine Hydrochloride12 in 1 BLISTER PACKCAPSULE122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-835DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [CVS PHARMACY, INC]2Current NDC, 7 package rows20241208_f4468840-e17c-6888-e053-2995a90a04a0.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-83551316-835-01, 51316-835-07, 51316-835-03, 51316-835-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incf4468840-e17c-6888-e053-2995a90a04a02024-12-02WarningsExact identifier
ndc (package): 51316-835-08
ndc (package): 51316-835-03
ndc (package): 51316-835-01
ndc (package): 51316-835-07
ndc (product): 51316-835
ndc11 (package): 51316083503
ndc11 (package): 51316083507
ndc11 (package): 51316083501
ndc11 (package): 51316083508
spl id: 28513391-e715-29a1-e063-6394a90a0340
spl set id: f4468840-e17c-6888-e053-2995a90a04a0

Reported adverse events (FAERS/openFDA)#

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