Allergy Relief Diphenhydramine HCl 25mg SoftGel

Manufacturer
NUVICARE LLC
Effective date
2025-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:05:51

Label at a glance#

ProductAllergy Relief Diphenhydramine HCl 25mg SoftGel
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 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 and over: 1 to 2 softgels ■ Children 6 years to under 12 years: 1 softgel ■ Children under 6 years: Do not use

Storage and handling

■ Store between 20º-25ºC (68º-77ºF). Avoid high humidity. Protect from moisture and light.

Label contents#

Full prescribing information#

Active Ingredient (In Each Softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

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

WARNINGS SECTION

Do not use:

■ to make a child sleepy

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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 

■ 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. 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 and over: 1 to 2 softgels
■ Children 6 years to under 12 years: 1 softgel
■ Children under 6 years: Do not use

Other Information:

STORAGE AND HANDLING SECTION

■ Store between 20º-25ºC (68º-77ºF). Avoid high humidity. Protect from moisture and light.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Polyethylene Glycol 400, Propylene Glycol, Gelatin, Glycerin, Sorbitol Sorbitan Solution, Purified Water

Questions Or Comments?

OTC - QUESTIONS SECTION

Call 1 (718) 337-8733 or email:support@nuvicare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0274-00PL0274-00

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1

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
84324-029-01Allergy Relief Diphenhydramine HCl 25mg SoftGel60 in 1 BOTTLECAPSULE, LIQUID FILLED601

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
84324-02984324-029-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLCbb728ceb-8eb0-4192-a8b0-742756819a052025-06-26WarningsExact identifier
ndc (package): 84324-029-01
ndc (product): 84324-029
ndc11 (package): 84324002901
spl id: 92deb47c-cf7f-4aff-8f4a-9c547e376a3e
spl set id: bb728ceb-8eb0-4192-a8b0-742756819a05

Reported adverse events (FAERS/openFDA)#

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