Allergy Relief

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:13

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 • itchy, watery eyes • sneezing • 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 doses in 24 hours  adults and children 12 years and older 1 to 2 softgels   children 6 to under 12 years 1 softgel   children under 6 years do not use 

Storage and handling

• store at 25°C (77°F) in a dry place • protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

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
• itchy, watery eyes
• sneezing
• 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
• difficulty in urination due to enlargement to the 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 beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution 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 doses in 24 hours

 adults and children 12 years and older1 to 2 softgels 
 children 6 to under 12 years1 softgel 
 children under 6 yearsdo not use 

Other information

STORAGE AND HANDLING SECTION

• store at 25°C (77°F) in a dry place
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Benadryl® Dye-Free Allergy*

RIGHT REMEDIES

READ AND KEEP OUTER PACKAGE FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson&Johnson Corporation, owner of the registered trademark Benadryl® Dye-Free Allergy.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816
Product of United Arab Emirates
Packaged and Quality Assured in the USA

REV.00-022022

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Strive-780Strive-780

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2

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
70692-780-16Allergy Relief2 in 1 CARTONCAPSULE, LIQUID FILLED22
70692-780-16Allergy Relief8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-780ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STRIVE PHARMACEUTICALS INC.]22 package rows20250101_de044b32-45a3-4589-814e-2f0ec869514f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-78070692-780-16

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
92bcd209-11ce-4de3-b02f-2fe252a7ca8bde044b32-45a3-4589-814e-2f0ec869514f2024-12-11WarningsExact identifier
spl id: 92bcd209-11ce-4de3-b02f-2fe252a7ca8b
spl set id: de044b32-45a3-4589-814e-2f0ec869514f

Reported adverse events (FAERS/openFDA)#

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