FDA.reportPublic FDA data

Kroger Aspirin 325 mg Tablets

Manufacturer
Kroger | TIME CAP LABORATORIES, INC.
Effective date
2024-04-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:11:07

Label at a glance#

ProductRegular Strength Aspirin 325 mg
Active ingredientASPIRIN
Label structure9 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)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • colds
  • minor pain of arthritis

temporarily reduces fever

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 and 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 include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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
  • if you have ever had an allergic reaction to this product or any of its ingredients

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

OTC - STOP USE SECTION

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:

  • feel faint
  • vomit blood
  • have bloody or black stools
  • 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
new symptoms occur
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 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
  • 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, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aspirin-300s-labelaspirin-300s-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
212033aspirin 325 MG Oral TabletPSN2
212033aspirin 325 MG Oral TabletSCD2
212033ASA 325 MG 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-011-32Regular StrengthAspirin 325 mg300 in 1 BOTTLETABLET, COATED3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-011REGULAR STRENGTH ASPIRIN 325 MG (ASPIRIN) TABLET, COATED [KROGER]2Current NDC, 1 package rows20240418_0fc3193d-af4e-ff3a-e063-6294a90a2743.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41226-01141226-011-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ASPIRINR16CO5Y76EACTIB

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
Regular Strength Aspirin 325 mgASPIRINKroger0fc3193d-af4e-ff3a-e063-6294a90a27432024-04-17WarningsExact identifier
ndc (package): 41226-011-32
ndc (product): 41226-011
ndc11 (package): 41226001132
spl id: 16490833-2c71-383f-e063-6294a90a7e61
spl set id: 0fc3193d-af4e-ff3a-e063-6294a90a2743

Reported adverse events (FAERS/openFDA)#

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