Allergy Relief

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:28:28

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 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 times in 24 hours. ■Adults and children 12 years and over: 1 to 2 tablets ■Children 6 years to under 12 years: 1 tablet ■Children under 6 years: Do not use

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • glaucoma
  • troble 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 times in 24 hours.
■Adults and children 12 years and over: 1 to 2 tablets
■Children 6 years to under 12 years: 1 tablet
■Children under 6 years: Do not use

OTHER INFORMATION

OTHER SAFETY INFORMATION

Each tablet contains: ■Calcium 24mg

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Opadry II 85G540006 Pink.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST.or visit www.gencare.health

SPL UNCLASSIFIED SECTION

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark BENADRYL® Tablets.

SPL UNCLASSIFIED SECTION

Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln, Suite A, East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0061 Rev 01 GC Allergy Relief 25mg 1000ct 02.26.2024_page-0001PL0061 Rev 01 GC Allergy Relief 25mg 1000ct 02.26.2024_page-0001

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X002ISMK8NPL0061 Rev 01 GC Allergy Relief 25mg 1000ct 02.26.2024_page-0001.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72090-021-102024-05-13C16284748780-1d6a99b39-de89-a426-e053-dadaa90af4c2ab45ed16-86bb-3faf-e053-2995a90acfbc
72090-021-102022-01-28C16284748780-1d6a99b39-de89-a426-e053-dadaa90af4c2ab45ed16-86bb-3faf-e053-2995a90acfbc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-021-10Allergy Relief1000 in 1 BOTTLETABLET10003

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72090-02172090-021-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ae97-7951-4058-e053-2995a90a7b2e2025-12-23WarningsExact identifier
ndc (product): 72090-021
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ed16-86bb-3faf-e053-2995a90acfbc2025-12-23WarningsExact identifier
ndc (package): 72090-021-10
ndc (product): 72090-021
ndc11 (package): 72090002110
spl id: 8caae1ca-d995-4416-861d-e28bddd9b3ac
spl set id: ab45ed16-86bb-3faf-e053-2995a90acfbc

Reported adverse events (FAERS/openFDA)#

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