FDA.reportPublic FDA data

Easy Care First Aid Diphenhydramine

Manufacturer
Tender Corporation
Effective date
2019-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:43

Label at a glance#

ProductEasy Care First Aid Diphenhydramine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies runny nose sneezing itching nose or throat itchy-watery eyes Temporarily relieves these symptoms due to the common cold runny nose sneezing

Dosage and administration

do not use more than directed Adults and children: (12 years and older) Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other respiratory allergies

  • runny nose
  • sneezing
  • itching nose or throat
  • itchy-watery eyes

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 that is used on skin.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

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 alcohol beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating 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 the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, contact a physician or poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed

SPL UNCLASSIFIED SECTION

Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

SPL UNCLASSIFIED SECTION

Children under 12 years:

Do not give to children under 12 years of age.

Other information

SPL UNCLASSIFIED SECTION

  • each caplet may contain: calcium 25mg
  • protect from light
  • use by expiration date on packet
  • store at room temperature 59º-86ºF (15º-30ºC
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide

* may contain

Easy Care First Aid Diphenhydramine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 Caplet

Made in USA

See card for complete product information

DiphenhydramineDiphenhydramine

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
44224-0017-12021-01-29C16284748780-1ba0f9c33-1f22-a910-e053-dadaa90a0b85Easy Care First Aid Ibuprofen
44224-0017-22021-01-29C16284748780-1ba0f9c33-1f22-a910-e053-dadaa90a0b85Easy Care First Aid Ibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44224-0017-1Easy Care First Aid Diphenhydramine1 in 1 PACKETTABLET, FILM COATED11
44224-0017-2Easy Care First Aid Diphenhydramine1 in 1 PACKETTABLET, FILM COATED11
44224-0017-2Easy Care First Aid Diphenhydramine50 in 1 BOXTABLET, FILM COATED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44224-0017EASY CARE FIRST AID DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TENDER CORPORATION]1Legacy NDC, 3 package rows20191004_9405f355-4b71-1caf-e053-2a95a90af018.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
44224-001744224-0017-2, 44224-0017-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 272LRS185U6KIACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
9405f355-4b72-1caf-e053-2a95a90af0189405f355-4b71-1caf-e053-2a95a90af0182019-10-03WarningsExact identifier
spl id: 9405f355-4b72-1caf-e053-2a95a90af018
spl set id: 9405f355-4b71-1caf-e053-2a95a90af018

Reported adverse events (FAERS/openFDA)#

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