Allergy Relief

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:41:32

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 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 do not take more than 6 doses in 24 hours  adults & children 12 years & over 1 to 2 tablets   children 6 to under 12 years 1 tablet  children under 6 years do not use this product in children under 6 years of age

Label contents#

Full prescribing information#

Active Ingredient

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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
 adults & children 12 years & over1 to 2 tablets 
 children 6 to under 12 years1 tablet
 children under 6 yearsdo not use this product in children under 6 years of age

Other information

OTHER SAFETY INFORMATION

• each tablet contains: calcium 24 mg • store between 15–30°C (59–86°F) • protect from moisture and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

CABINET HEALTH P.B.C.

Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in: Benadryl® Allergy*

Diphenhydramine HCl 25 mg**

Relieves:
Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat

**May cause drowsiness

Allergy Pouch FrontAllergy Pouch Front

Allergy Pouch BackAllergy Pouch Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN4
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD4

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
68210-4229-3Allergy Relief300 in 1 POUCHTABLET, FILM COATED3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4229ALLERGY RELIEF (DIPHENHYDRAIME HCL) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20241211_18df23eb-1f3d-4936-b9bd-e5d71d100bcb.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-422968210-4229-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
28de35d0-7e3d-dfb1-e063-6294a90a1e5618df23eb-1f3d-4936-b9bd-e5d71d100bcb2024-12-09WarningsExact identifier
spl id: 28de35d0-7e3d-dfb1-e063-6294a90a1e56
spl set id: 18df23eb-1f3d-4936-b9bd-e5d71d100bcb

Reported adverse events (FAERS/openFDA)#

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