Allergy Relief Caplet

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2025-01-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:51:44

Label at a glance#

ProductAllergy Relief Caplet
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  • 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 over  1 to 2 tablets  children 6 to under 12 years  1 tablet  children under 6 years  do not use

Storage and handling

•  store between 20-25°C (68-77°F) • avoid excessive heat, cold and humidity • close cap tightly after use

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  • 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 any other product 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. 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 over 1 to 2 tablets
 children 6 to under 12 years 1 tablet
 children under 6 years do not use

Other information

STORAGE AND HANDLING SECTION

• store between 20-25°C (68-77°F)
• avoid excessive heat, cold and humidity
• close cap tightly after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate DT, D&C red #27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments:

OTC - QUESTIONS SECTION

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

COMPARE TO BENADRYL® ALLERGY ULTRATAB® ACTIVE INGREDIENT*

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

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark Benadryl® Allergy ULTRATAB®.

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO STVA1023
topcare@topco.com
www.topcarebrand.com
PRODUCT OF INDIA

QUALITY GUARANTEED

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-937-01Allergy Relief Caplet1 in 1 CARTONTABLET, FILM COATED15
36800-937-01Allergy Relief Caplet100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
36800-937-40Allergy Relief Caplet400 in 1 BOTTLETABLET, FILM COATED4005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-937ALLERGY RELIEF CAPLET (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 3 package rows20250112_126c05e7-2cd9-47d3-96c3-82305714e1db.zip

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
36800-93736800-937-40, 36800-937-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 Relief CapletDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC126c05e7-2cd9-47d3-96c3-82305714e1db2025-01-02WarningsExact identifier
ndc (package): 36800-937-01
ndc (package): 36800-937-40
ndc (product): 36800-937
ndc11 (package): 36800093740
ndc11 (package): 36800093701
spl id: 452adf86-1162-449c-a974-469bfaa20da9
spl set id: 126c05e7-2cd9-47d3-96c3-82305714e1db

Reported adverse events (FAERS/openFDA)#

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