Only For ALLERGY

Manufacturer
O4 Global Trading Usa, Llc
Effective date
2020-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:44

Label at a glance#

ProductOnly For ALLERGY
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 doctor • do not take more than 6 doses in 24 hours  adults and children 12 years and over • take 1 to 2 caplets   children 6 to under 12 years • take 1 caplet  children under 6 years • do not use

Storage and handling

• store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F). • avoid excessive heat and light. • store in dry place.

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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

 adults and children 12 years and over• take 1 to 2 caplets 
 children 6 to under 12 years• take 1 caplet
 children under 6 years• do not use

Other Information:

STORAGE AND HANDLING SECTION

• store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F).
• avoid excessive heat and light.
• store in dry place.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-833-665-9444.
(Mon-Fri 9am - 5pm)

SPL UNCLASSIFIED SECTION

ANTIHISTAMINE NIGHTTIME SLEEP-AID

TAMPER EVIDENT Do not use if imprinted safety seal under cap is broken or missing

Distributed By: O4 GLOBAL TRADING USA, LLC.
12222 Merit Drive, Suite 1900
Dallas, TX 75251-3209

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc.
East Brunswick, NJ 08816.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73006-148-952023-01-30C16284748780-1f386c64a-0639-0266-e053-dadaa90a7c1aOnly For ™ ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73006-148-95Only For ALLERGY25 in 1 BOTTLE, PLASTICTABLET251
73006-148-95Only For ALLERGY1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73006-148ONLY FOR ALLERGY (DIPHENHYDRAMINE HCL) TABLET [O4 GLOBAL TRADING USA, LLC]1Legacy NDC, 2 package rows20201224_5d4b2c79-9580-44a4-9f9f-f9a006d47143.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73006-14873006-148-95

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
93e01654-953a-4541-b44f-fb5daa7a9ecb5d4b2c79-9580-44a4-9f9f-f9a006d471432020-11-18WarningsExact identifier
spl id: 93e01654-953a-4541-b44f-fb5daa7a9ecb
spl set id: 5d4b2c79-9580-44a4-9f9f-f9a006d47143

Reported adverse events (FAERS/openFDA)#

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