Allergy Relief

Manufacturer
HealthLife of USA LLC | HHH PHARMA USA, LLC dba/HHH Pharmaceuticals | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2026-10-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-07 01:02:56

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.

Dosage and administration

Adults and children 12 years  and over: 1 or 2 caplet (s) Children 6 to under 12 years of age: 1 caplet Children under 6 years of age: do not use; Do not take more than 6 caplets a day.

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses:

INDICATIONS & USAGE SECTION

  • Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.

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

  • Trouble urinating due to an enlarged prostate gland
  • Glaucoma
  • A breathing problem such as emphysema or chronic bronchitis

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 drinks, may cause drowsy.
  • Excitability may occur, especially in children.
  • Be careful when driving a motor vehicle or operating machinery.

Stop use and ask doctor if 

OTC - STOP USE SECTION

symptoms not relieved within seven days usage, please contact physician or health care provider.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years  and over:1 or 2 caplet (s)
Children 6 to under 12 years of age:1 caplet
Children under 6 years of age:do not use; Do not take more than 6 caplets a day.

Other Information

OTHER SAFETY INFORMATION

  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Read all product information before use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Colloidal silicon Dioxide, Croscarmellose sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), D&C Red 27,  Titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free  1-844-832-1138

Monday through Friday 9AM- 5PM EST

PRINCIPAL DISPLAY PANEL-100 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

PRINCIPAL DISPLAY PANEL-300 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

PRINCIPAL DISPLAY PANEL-600 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

PRINCIPAL DISPLAY PANEL-1000 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369517003011GTIN-13: 0369517003011
EAN-13: 0369517003011
GTIN-12: 369517003011
UPC-A: 369517003011
GTIN storage (14 digits): 00369517003011
label-100.jpg
BarcodeEAN-130369517003103GTIN-13: 0369517003103
EAN-13: 0369517003103
GTIN-12: 369517003103
UPC-A: 369517003103
GTIN storage (14 digits): 00369517003103
label-1000.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

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-00369517-003-01, 69517-003-03, 69517-003-06, 69517-003-10

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-09-17full-release2026-06-01 01:14:18

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
5cfc6bb0-0483-27a5-e063-6394a90a8d2ca73d20df-3df7-42f7-8c88-93fee7e9ccec2026-10-03WarningsExact identifier
spl id: 5cfc6bb0-0483-27a5-e063-6394a90a8d2c
spl set id: a73d20df-3df7-42f7-8c88-93fee7e9ccec

Reported adverse events (FAERS/openFDA)#

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