Allergy Relief

Manufacturer
Marc Glassman, Inc.
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:29:06

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 do not exceed 6 doses in 24 hours adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 capsules) children 6 to under 12 years of age 12.5 mg 12.5 mg dosage strength is not available in this package. Do not attempt to break capsules. to 25 mg (1 capsule) children under 6 years of age ask a doctor

Storage and handling

store at room temperature 15°-30°C (59°-86°F) protect from moisture retain carton for complete product information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

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

OTC - DO NOT USE SECTION

Do not use 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

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not exceed 6 doses in 24 hours
adults and children 12 years of age and over25 mg to 50 mg (1 to 2 capsules)
children 6 to under 12 years of age12.5 mg * to 25 mg (1 capsule)
children under 6 years of ageask a doctor

* 12.5 mg dosage strength is not available in this package. Do not attempt to break capsules.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F)
  • protect from moisture
  • retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Marc’s®

†Compare to the active ingredient in Benadryl® Allergy

Allergy Relief

Diphenhydramine HCl

ANTIHISTAMINE

For Relief of

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat

Actual Size

24 CAPSULES

image descriptionimage description

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68998-113-01Allergy Relief2 in 1 CARTONCAPSULE23
68998-113-01Allergy Relief12 in 1 BLISTER PACKCAPSULE123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-113ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [MARC GLASSMAN, INC.]3Current NDC, Legacy NDC, 2 package rows20241025_5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68998-11368998-113-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 ReliefDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb2024-10-23WarningsExact identifier
ndc (package): 68998-113-01
ndc (product): 68998-113
ndc11 (package): 68998011301
spl id: 2526733b-b4b4-6a89-e063-6294a90a23d4
spl set id: 5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb

Reported adverse events (FAERS/openFDA)#

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