Timely Extra Strength Acetaminophen 500 mg Gelcaps
- Manufacturer
- TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2026-06-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-08-11 01:01:42
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
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 haveliver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you aretaking 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.
OVERDOSAGE SECTION
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 between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)
- avoid high humidity
INACTIVE INGREDIENT SECTION
Inactive ingredientscolloidal 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 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Acetaminophen 500 mg - 100 count Label
Products#
Every source-derived product name is available through these pages.
- Extra Strength Acetaminophen
- Acetaminophen
- TITANIUM DIOXIDE
- POVIDONE
- FD&C YELLOW NO. 6
- FOOD YELLOW 3 FREE ACID
- FD&C RED NO. 40
- FERRIC OXIDE YELLOW
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STEARIC ACID
- TALC
- SILICON DIOXIDE
- D&C RED NO. 33
- FD&C BLUE NO. 1
- FERRIC OXIDE RED
- FERROSOFERRIC OXIDE
- GELATIN
- CROSCARMELLOSE SODIUM
- STARCH, CORN
- HYPROMELLOSE, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49483-673 | 49483-673-73 |
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 |
|---|---|---|---|---|---|---|
| Extra Strength Acetaminophen | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 58840cf4-aceb-c7cf-e063-6294a90a5ff4 | 2026-06-01 | Warnings | 49483-673-73 49483-673 49483067373 58840cb3-368d-c7a4-e063-6294a90a2d3f 58840cf4-aceb-c7cf-e063-6294a90a5ff4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
