LEADER

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-18 01:00:50

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• temporarily relieves these symptoms due to hay fever or 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 older 1 to 2 capsules children 6 to under 12 years old 1 capsule children under 6 years old do not use

Storage and handling

• store at 20 – 25°C (68–77°F) • protect from light, heat and moisture

Label contents#

Full prescribing information#

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 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 other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers

When using this product
• marked 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

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.
Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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 older

1 to 2 capsules
children 6 to under 12 years old1 capsule
children under 6 years olddo not use

Other information

STORAGE AND HANDLING SECTION

• store at 20 – 25°C (68–77°F)
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, D&C red no. 28, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate-80, propylparaben, purified water, sodium lauryl sulphate, starch

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

LEADER™

NDC 70000-0771-2
NDC 70000-0771-1

Allergy Relief
Diphenhydramine HCl, 25 mg | Antihistamine

Allergy Relief For:
Sneezing, Runny Nose,
Itchy, Watery Eyes,
Itchy Throat

COMPARE TO
BENADRYL®
ALLERGY
active ingredient*

100% Money Back Guarantee

24 CAPSULES

100 CAPSULES

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

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 Kenvue, Inc., owner of the registered trademark Benadryl® Allergy.

©2026 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. 

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Product of India

All LEADER™ Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

CIN 6128680 REV. 04/26

CT7000007712 REV.00-042026

CIN 6128672 REV. 04/26

REV.00-042026 LB7000007711

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LeaderAllergy ReliefLeaderAllergy Relief

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-077170000-0771-1, 70000-0771-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-08-14daily-update2026-08-21 02:01:46

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
ceafb988-d40d-4e92-bb23-d9a2c1893da8519c86dd-fa86-5de2-e063-6394a90a462b2026-08-14WarningsExact identifier
spl set id: 519c86dd-fa86-5de2-e063-6394a90a462b

Reported adverse events (FAERS/openFDA)#

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