FDA.reportPublic FDA data

Regular Strength Aspirin EC

Manufacturer
H.J. Harkins Company, Inc. | Major Pharmaceuticals Inc | Time Cap Labs Inc
Effective date
2011-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:30:23

Label at a glance#

ProductRegular Strength Aspirin EC
Active ingredientASPIRIN
Label structure14 sections

Storage and handling

Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)                  Purpose

Aspirin 325 mg (NSAID*).............................Pain reliever

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose
Pain reliever

INDICATIONS & USAGE SECTION

Uses
  • for the temporary relief of minor aches and pains due to
    • headache
    • colds
    • muscle pain
    • menstrual pain
    • toothache
    • minor pain of arthritis
  • or as directed by your doctor

WARNINGS SECTION

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may inclue:
  • hives
  • facial swelling
  • shock
  • asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

OTC - DO NOT USE SECTION

Do not use
  • if you are allergic to aspirin or any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
  • you have not been drinking fluids

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drugs
  • under a doctor's care for any serious condition

OTC - STOP USE SECTION

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

STORAGE AND HANDLING SECTION

Other information
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

OTC - QUESTIONS SECTION

Questions? To Report Adverse Drug Event Call: (800) 616-2471

Repacked by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGE OF BOTTLE LABEL
IMAGE OF BOTTLE LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN2
198467aspirin 325 MG Delayed Release Oral TabletSCD2
198467ASA 325 MG Delayed Release Oral TabletSY2
198467aspirin 325 MG Enteric Coated Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-018-002020-01-31C16284748780-19d75b9d0-dc21-f424-e053-dadaa90a57ceDRUG FACTS
52959-018-142020-01-31C16284748780-19d75b9d0-dc21-f424-e053-dadaa90a57ceDRUG FACTS
52959-018-202020-01-31C16284748780-19d75b9d0-dc21-f424-e053-dadaa90a57ceDRUG FACTS
52959-018-242020-01-31C16284748780-19d75b9d0-dc21-f424-e053-dadaa90a57ceDRUG FACTS
52959-018-302020-01-31C16284748780-19d75b9d0-dc21-f424-e053-dadaa90a57ceDRUG FACTS
52959-018-402020-01-31C16284748780-19d75b9d0-dc21-f424-e053-dadaa90a57ceDRUG FACTS
52959-018-602020-01-31C16284748780-19d75b9d0-dc21-f424-e053-dadaa90a57ceDRUG FACTS
52959-018-802020-01-31C16284748780-19d75b9d0-dc21-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-018-00Regular Strength Aspirin EC100 in 1 BOTTLETABLET, DELAYED RELEASE1002
52959-018-14Regular Strength Aspirin EC14 in 1 BOTTLETABLET, DELAYED RELEASE142
52959-018-20Regular Strength Aspirin EC20 in 1 BOTTLETABLET, DELAYED RELEASE202
52959-018-24Regular Strength Aspirin EC24 in 1 BOTTLETABLET, DELAYED RELEASE242
52959-018-30Regular Strength Aspirin EC30 in 1 BOTTLETABLET, DELAYED RELEASE302
52959-018-40Regular Strength Aspirin EC40 in 1 BOTTLETABLET, DELAYED RELEASE402
52959-018-60Regular Strength Aspirin EC60 in 1 BOTTLETABLET, DELAYED RELEASE602
52959-018-80Regular Strength Aspirin EC80 in 1 BOTTLETABLET, DELAYED RELEASE802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-018REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 8 package rows20111221_3c15ae1b-c88c-4e04-812d-91a57e77250f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-018-00EA - Each52959-018380fddb0-8702-43af-a5d9-8e82442ea2c812012-07-24
52959-018-14EA - Each52959-018b367573c-1381-4d13-bec3-f4efbee10f5c12012-07-24
52959-018-20EA - Each52959-018e3e987d4-dec9-4d01-9670-6d2bcb8d443e12012-07-24
52959-018-24EA - Each52959-0189b6a13a3-d3f5-4850-b492-ac5491d759ba12012-07-24
52959-018-30EA - Each52959-018026ef464-c76c-4dec-a39c-5812b48c299d12012-07-24
52959-018-40EA - Each52959-01817d7d3d3-b91c-439f-b378-1e9f2a77f77c12012-07-24
52959-018-60EA - Each52959-01805bee219-2976-44fd-9577-bcf06c3a81c812012-07-24
52959-018-80EA - Each52959-018a14f0c0c-9386-4fd7-8d39-9a9b1a3b806c12012-07-24
0904-2013-60EA - Each0904-2013c84ce7b9-9f6f-4975-8189-fae1baf2231b12012-07-24
0904-2013-72EA - Each0904-2013b1d173aa-914a-48c8-9050-e6fceae291bf12012-07-24
0904-2013-80EA - Each0904-2013553a24cd-9975-414f-8b60-671e643bf56812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E2
ASPIRINACTIVE MOIETYR16CO5Y76E2

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52959-01852959-018-14, 52959-018-20, 52959-018-24, 52959-018-30, 52959-018-40, 52959-018-60, 52959-018-80, 52959-018-00
0904-2013

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
HYPROMELLOSE 2910 (15 MPA.S)36SFW2JZ0WIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POLYSORBATE 806OZP39ZG8HIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT

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
b761ebd8-e9bb-46d1-9671-8e59373f51f63c15ae1b-c88c-4e04-812d-91a57e77250f2011-12-20WarningsExact identifier
spl id: b761ebd8-e9bb-46d1-9671-8e59373f51f6
spl set id: 3c15ae1b-c88c-4e04-812d-91a57e77250f

Reported adverse events (FAERS/openFDA)#

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