Allergy Relief

Manufacturer
Advanced Rx LLC
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:19

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itchy nose or throat temporarily relieves these symptoms of 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 doses in 24 hours Adults and children 12 years and over: 1 or 2 caplets Children 6 to under 12 years of age: 1 caplet Children under 6 years of age:  do not use

Storage and handling

Each caplet contains: Calcium 23.52 mg store at controlled room temperature 20°-25°C (68°-77°F) read all product information before using. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

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

Warnings

WARNINGS SECTION

do not use

OTC - DO NOT USE SECTION

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

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 your 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
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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.

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.

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

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

Adults and children 12 years and over:1 or 2 caplets

Children 6 to under 12 years of age:1 caplet

Children under 6 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • Each caplet contains:Calcium 23.52 mg
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-630-8895

Monday through Friday 9 AM - 5 PM EST.

SPL UNCLASSIFIED SECTION

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN THE USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80513-722-06

Compare to Benadryl ®Allergy Ultratab ®active ingredient*

ALLERGY RELIEF

DIPHENHYDRAMINE HCl 25 mg

ANTIHISTAMINE

RELIEVES:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

600

MINI TABLETS

*This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl ®Allergy Ultratab ®

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

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
80513-722-06Allergy Relief600 in 1 BOTTLETABLET6002

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80513-72280513-722-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 HCLAdvanced Rx LLC20e164b8-4cbc-cf3f-e063-6394a90a9d0c2025-07-02WarningsExact identifier
ndc (package): 80513-722-06
ndc (product): 80513-722
ndc11 (package): 80513072206
spl id: 38ec4df3-7638-3adf-e063-6394a90a0cec
spl set id: 20e164b8-4cbc-cf3f-e063-6394a90a9d0c

Reported adverse events (FAERS/openFDA)#

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