Kroger Extra Strength Acetaminophen Rapid Release Tablets

Manufacturer
Kroger Company | Time Cap Laboratories, Inc. | MARKSANS PHARMA LIMITED
Effective date
2024-04-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:02

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever

WARNINGS SECTION

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
•more than 4,000 mg of acetaminophen in 24 hours
•with other drugs containing acetaminophen
•3 or more alcoholic drinks every day while using this product

Allergy alert: 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.

OTC - DO NOT USE SECTION

Do not use
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
•if you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop use and ask a doctor if
•pain gets worse or lasts more than 10 days
•fever gets worse or lasts more than 3 days
•new symptoms occur
•redness or swelling is present
These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed (see overdose warning)

adults and children 12 years and over

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children under 12 years

  • ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, mica based pearlescent pigment, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, povidone, pregelatinized starch

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

apap-rr-225s-labelapap-rr-225s-labelapap-rr-100s-labelapap-rr-100s-labelapap-rr-100s-ifcapap-rr-100s-ifcacetaminophen 500 mg-24ct-cartonacetaminophen 500 mg-24ct-carton

acetaminophen 500 mg-24ct-Bottle labelacetaminophen 500 mg-24ct-Bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN3
198440acetaminophen 500 MG Oral TabletSCD3
198440APAP 500 MG Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-697-01ACETAMINOPHEN100 in 1 BOTTLETABLET, COATED1003
41226-697-01ACETAMINOPHEN1 in 1 CARTONTABLET, COATED13
41226-697-34ACETAMINOPHEN225 in 1 BOTTLETABLET, COATED2253
41226-697-42ACETAMINOPHEN24 in 1 BOTTLETABLET, COATED243
41226-697-42ACETAMINOPHEN1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-697ACETAMINOPHEN TABLET, COATED [KROGER COMPANY]3Current NDC, Legacy NDC, 5 package rows20240415_bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41226-69741226-697-42, 41226-697-34, 41226-697-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
ACETAMINOPHENACETAMINOPHENKroger Companybbeebdd6-fe2c-5b8a-e053-2a95a90ab95e2024-04-13WarningsExact identifier
ndc (package): 41226-697-34
ndc (package): 41226-697-01
ndc (package): 41226-697-42
ndc (product): 41226-697
ndc11 (package): 41226069742
ndc11 (package): 41226069734
ndc11 (package): 41226069701
spl id: 15f7c6af-1e4d-c8ee-e063-6394a90a9e58
spl set id: bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e

Reported adverse events (FAERS/openFDA)#

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