FDA.reportPublic FDA data

Allergy Relief

Manufacturer
We Care Distributor Inc | Elysium Pharmaceutical Ltd.
Effective date
2016-02-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:52

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 times in 24 hours adults and children 12 years and over - 1 to 2 caplets children 6 to under 12 years - 1 caplets children under 6 years - do not use

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

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

OTC - DO NOT USE SECTION


  • 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

When using this product

OTC - WHEN USING SECTION


  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating a machinery
  • excitability may occur, especially in children

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, 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 caplets
  • children 6 to under 12 years - 1 caplets
  • children under 6 years - do not use

Other Information

SPL UNCLASSIFIED SECTION


  • each caplet contains; calcium 20 mg
  • store between 20-25 C (68-77 F), Avoid high humidity. Protect from light.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmallose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, titanium dioxide, d and c red, lecithin, polyvinyl alcohol, polyethylene glycol, talc.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70005-001-25

We Care

For Good Health

ALLERGY RELIEF

COMPARE TO THE ACTIVE INGREDIENT IN

Benadryl

CAPSULES

TO OPEN PUSH IN TAB AND PULL OUT

Diphenhydramine HCL, 25 mg

Antihistamine

Relieves:

  • Sneezing
  • Itchy Watery Eyes
  • Runny Nose
  • Itchy Throat

This product is not manufactured or distributed by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark of Benadryl Capsules.

25 Pouches of 2 Coated Caplets

image 25image 25


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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-001-022020-01-31C16284748780-19d75b9d0-324d-f424-e053-dadaa90a57ceDrug Facts
70005-001-252020-01-31C16284748780-19d75b9d0-324d-f424-e053-dadaa90a57ceDrug Facts
70005-001-502020-01-31C16284748780-19d75b9d0-324d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-001-02Allergy Relief2 in 1 BOXTABLET22
70005-001-02Allergy Relief2 in 1 POUCHTABLET22
70005-001-25Allergy Relief25 in 1 BOXTABLET252
70005-001-25Allergy Relief2 in 1 POUCHTABLET22
70005-001-50Allergy Relief50 in 1 BOXTABLET502
70005-001-50Allergy Relief2 in 1 POUCHTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-001ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WE CARE DISTRIBUTOR INC]2Legacy NDC, 6 package rows20160204_8975e347-ab18-4c6d-bc36-fb2b889130c3.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
70005-00170005-001-25, 70005-001-50, 70005-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYVINYL ALCOHOL532B59J990IACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT
D&C RED NO. 272LRS185U6KIACT

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
44f9f277-7a42-4b14-850e-a88627a641268975e347-ab18-4c6d-bc36-fb2b889130c32016-02-02WarningsExact identifier
spl id: 44f9f277-7a42-4b14-850e-a88627a64126
spl set id: 8975e347-ab18-4c6d-bc36-fb2b889130c3

Reported adverse events (FAERS/openFDA)#

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