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#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
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
- 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
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-697-01 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET, COATED | 100 | 3 | |
| 41226-697-01 | ACETAMINOPHEN | 1 in 1 CARTON | TABLET, COATED | 1 | 3 | |
| 41226-697-34 | ACETAMINOPHEN | 225 in 1 BOTTLE | TABLET, COATED | 225 | 3 | |
| 41226-697-42 | ACETAMINOPHEN | 24 in 1 BOTTLE | TABLET, COATED | 24 | 3 | |
| 41226-697-42 | ACETAMINOPHEN | 1 in 1 CARTON | TABLET, COATED | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- POVIDONE K30
- STARCH, CORN
- MICA
- POLYETHYLENE GLYCOL 400
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- HYPROMELLOSE 2910 (6 MPA.S)
- MAGNESIUM STEARATE
- POLYSORBATE 80
- CROSPOVIDONE
- POLYETHYLENE GLYCOL 6000
- CROSCARMELLOSE SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41226-697 | 41226-697-42, 41226-697-34, 41226-697-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MICA | V8A1AW0880 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| POLYETHYLENE GLYCOL 6000 | 30IQX730WE | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | Kroger Company | bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e | 2024-04-13 | Warnings | 41226-697-34 41226-697-01 41226-697-42 41226-697 41226069742 41226069734 41226069701 15f7c6af-1e4d-c8ee-e063-6394a90a9e58 bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.




