Acetaminophen Gelcaps
- Manufacturer
- Kroger | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-05-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:33
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each gelcap)
Acetaminophen USP 500 mg
OTC - PURPOSE SECTION
Purpose
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 |
|
| children under 12 years | ask a doctor |
OTHER SAFETY INFORMATION
Other information
- each gelcap contains: sodium 1 mg
- store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)
- avoid high humidity
INACTIVE INGREDIENT SECTION
Inactive ingredients colloidal anhydrous silica, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, gelatin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-800-632-6900
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Acetaminophen 500 mg Gelcaps 24ct carton
Acetaminophen 500 mg Gelcaps 24ct Label
Acetaminophen 500 mg Gelcaps 100ct carton
Acetaminophen 500 mg Gelcaps 100ct Label
Acetaminophen 500 mg Gelcaps 225ct carton
Acetaminophen 500 mg Gelcaps 225ct label
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-673-01 | Acetaminophen Gelcaps | 1 in 1 CARTON | TABLET | 1 | 2 | |
| 41226-673-01 | Acetaminophen Gelcaps | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 41226-673-26 | Acetaminophen Gelcaps | 1 in 1 CARTON | TABLET | 1 | 2 | |
| 41226-673-26 | Acetaminophen Gelcaps | 225 in 1 BOTTLE | TABLET | 225 | 2 | |
| 41226-673-42 | Acetaminophen Gelcaps | 1 in 1 CARTON | TABLET | 1 | 2 | |
| 41226-673-42 | Acetaminophen Gelcaps | 24 in 1 BOTTLE | TABLET | 24 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Gelcaps
- Acetaminophen
- D&C RED NO. 33
- FERRIC OXIDE YELLOW
- TALC
- FD&C RED NO. 40
- STARCH, CORN
- TITANIUM DIOXIDE
- FERROSOFERRIC OXIDE
- HYPROMELLOSE, UNSPECIFIED
- STEARIC ACID
- CROSCARMELLOSE SODIUM
- FERRIC OXIDE RED
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- POVIDONE
- SILICA
- GELATIN, UNSPECIFIED
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41226-673 | 41226-673-42, 41226-673-01, 41226-673-26 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 Gelcaps | ACETAMINOPHEN | Kroger | 30d3f2d0-da35-7f6f-e063-6294a90a9c22 | 2025-05-23 | Warnings | 41226-673-01 41226-673-42 41226-673-26 41226-673 41226067326 41226067342 41226067301 35c77089-5b97-bf0d-e063-6294a90aada3 30d3f2d0-da35-7f6f-e063-6294a90a9c22 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.





