diphenhydramine hydrochloride - HF Acquisition Co LLC, DBA HealthFirst

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:52:12

Label at a glance#

Productdiphenhydramine hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

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

Dosage and administration

Do not use – Diphen Allergy Caplet to make a child sleepy with any other product containing diphenhydramine, even one that is used on skin. Ask a doctor before use if you have – Diphen Allergy Caplet a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet taking sedatives or tra...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

OTC - PURPOSE SECTION

Antihistamine

USES

SPL UNCLASSIFIED SECTION

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

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

Temporarily relieves these symptoms due to the common cold

runny nose
sneezing

WARNINGS SECTION

Do not use – Diphen Allergy Caplet

to make a child sleepy
with any other product containing diphenhydramine, even one that is used on skin.

Ask a doctor before use if you have – Diphen Allergy Caplet

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

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

When using this product – Diphen Allergy Caplet

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase the drowsiness effect
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

If pregnant or breast-feeding, – Diphen Allergy Caplet

ask a health care professional before use.

Keep out of reach of children. – Diphen Allergy Caplet

In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

DIRECTIONS

SPL UNCLASSIFIED SECTION

Do not use – Diphen Allergy Caplet
to make a child sleepy
with any other product containing diphenhydramine, even one that is used on skin.
Ask a doctor before use if you have – Diphen Allergy Caplet
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma
Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet
taking sedatives or tranquilizers
When using this product – Diphen Allergy Caplet
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase the drowsiness effect
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children
If pregnant or breast-feeding, – Diphen Allergy Caplet
ask a health care professional before use.

Keep out of reach of children. – Diphen Allergy Caplet
In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

OTHER SAFETY INFORMATION

protect from light
store at room temperature 68º-77ºF (20º-25ºC)
tamper-evident sealed packets
do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN

OTC - DO NOT USE SECTION

Do not use – Diphen Allergy Caplet

to make a child sleepy
with any other product containing diphenhydramine, even one that is used on skin.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have – Diphen Allergy Caplet

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

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product – Diphen Allergy Caplet

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase the drowsiness effect
use caution 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, – Diphen Allergy Caplet

ask a health care professional before use.

DOSAGE & ADMINISTRATION SECTION

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

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

Temporarily relieves these symptoms due to the common cold

runny nose
sneezing

INDICATIONS & USAGE SECTION

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

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

Temporarily relieves these symptoms due to the common cold

runny nose
sneezing

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3

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
51662-1674-1diphenhydramine hydrochloride1 in 1 PACKETTABLET, FILM COATED13

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
51662-167451662-1674-1
47682-167

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-11-21monthly-update2026-06-03 17:40:35

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 HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst44217a8c-7656-a0f6-e063-6294a90af2ad2026-03-31WarningsExact identifier
ndc (package): 51662-1674-1
ndc (product): 51662-1674
ndc11 (package): 51662167401
spl id: 4e5741df-24d9-1cab-e063-6294a90a2534
spl set id: 44217a8c-7656-a0f6-e063-6294a90af2ad
Medique DiphenDIPHENHYDRAMINE HYDROCHLORIDEUnifirst First Aid Corporationb61ee2e0-2543-447d-9fc4-23363d46ce042025-09-08WarningsExact identifier
ndc (product): 47682-167

Reported adverse events (FAERS/openFDA)#

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