allergy relief

Manufacturer
Strategic Sourcing Services, LLC (Health Mart) | LNK International, Inc.
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 20:39:48

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 itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

do not take more than directed 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 to under 12 years 1 tablet children under 6 years do not use

Storage and handling

each tablet contains: calcium 30 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from moisture see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • 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 over1 to 2 tablets
children 6 to under 12 years
1 tablet
children under 6 years
do not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Health Mart®

NDC 62011-0310-1

Compare to Benadryl®
Allergy ULTRATAB® Tablets
active ingredient*

Allergy Relief
Diphenhydramine HCl, 25 mg
Antihistamine

Relieves Sneezing • Runny nose
• Itchy, Watery eyes
• Itchy throat

ACTUAL SIZE

24 Minitabs

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Benadryl®
Allergy ULTRATAB® Tablets.
50844          REV0721D32908

Distributed by McKesson Corp., via
Strategic Sourcing Services LLC,
Memphis, TN 38141
© 2011 McKesson Corporation
www.healthmart.com
Money Back Guarantee

44-329
44-329

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0310ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES, LLC (HEALTH MART)]16Legacy NDC20250411_25f16fb8-997c-4b2b-b530-aed7eef79f22.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0310-1EA - Each62011-0310264744e6-957d-40f5-9aa0-f53f81cff0e212017-11-06

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
62011-031062011-0310-1, 62011-0310-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
6a264e01-c27c-4d02-8c18-f6936450d42925f16fb8-997c-4b2b-b530-aed7eef79f222025-04-10WarningsExact identifier
spl id: 6a264e01-c27c-4d02-8c18-f6936450d429
spl set id: 25f16fb8-997c-4b2b-b530-aed7eef79f22

Reported adverse events (FAERS/openFDA)#

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