FDA.reportPublic FDA data

Easy Care First Aid Acetaminophen

Manufacturer
Unifirst First Aid 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 Acetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains associated with headache toothache minor arthritis pain muscular aches common cold menstrual cramps For the reduction of fever.

Dosage and administration

do not use more than directed Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with

  • headache
  • toothache
  • minor arthritis pain
  • muscular aches
  • common cold
  • menstrual cramps

For the reduction of fever.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug
    contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • pain or fever persists or gets worse
  • new symptoms occur
  • redness or swelling is present
OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed

Adults and children: (12 years and older)

SPL UNCLASSIFIED SECTION

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

SPL UNCLASSIFIED SECTION

Do not give this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may

cause liver damage.

Other information

SPL UNCLASSIFIED SECTION

  • 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

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* May contain

Easy Care First Aid Acetaminophen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 Tablets

See Card for Complete Product Information

AcetaminophenAcetaminophen

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44224-0016-12021-01-29C16284748780-1ba0f9c33-5bd4-a910-e053-dadaa90a0b85Easy Care Acetaminophen 500 mg
44224-0016-22021-01-29C16284748780-1ba0f9c33-5bd4-a910-e053-dadaa90a0b85Easy Care Acetaminophen 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44224-0016-1Easy Care First Aid Acetaminophen2 in 1 PACKETTABLET, FILM COATED21
44224-0016-2Easy Care First Aid Acetaminophen50 in 1 BOXTABLET, FILM COATED501
44224-0016-2Easy Care First Aid Acetaminophen2 in 1 PACKETTABLET, FILM COATED21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44224-0016EASY CARE FIRST AID ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]1Legacy NDC, 3 package rows20191004_9404c1e6-deb4-4d12-e053-2995a90a1346.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44224-001644224-0016-2, 44224-0016-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYPROMELLOSES3NXW29V3WOIACT
MALTODEXTRIN7CVR7L4A2DIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
9404c60f-6c11-4d31-e053-2995a90a82749404c1e6-deb4-4d12-e053-2995a90a13462019-10-03WarningsExact identifier
spl id: 9404c60f-6c11-4d31-e053-2995a90a8274
spl set id: 9404c1e6-deb4-4d12-e053-2995a90a1346

Reported adverse events (FAERS/openFDA)#

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