Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis muscular aches toothache premenstrual and menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis muscular aches toothache premenstrual and menstrual cramps temporarily reduces fever
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
store at 20º - 25ºC (68º -77ºF)
Drug Facts
Acetaminophen 500 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
Do not use
Ask a doctor before use if you have
Ask a doctor/pharmacist before use if you are
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
Overdose warning: In case of overdose, get medical help or contact a Poison Control (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Adults and children 12 years and over:
Children under 12 Years
Pregelatinzed starch, Polyvinyl pyrrolidone, stearic acid powder, microcrystalline cellulose, magnesium stearate, Hypromellose-5, Hypromellose-15, polyethlene glycol 400, titanium dioxide, talc
Call 1 (718) 337-8733 or visit: support@nuvicare.com
This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tyleno® Extra Strength Caplets.
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84324-021-01 | ACETAMINOPHEN 500 MG | 100 in 1 BOTTLE | TABLET | 100 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84324-021 | 84324-021-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TALC | 7SEV7J4R1U | IACT |
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 500 MG | ACETAMINOPHEN | NUVICARE LLC | 591ee107-e953-4982-b75f-13a0afd7c4ae | 2025-12-19 | Warnings | 84324-021-01 84324-021 84324002101 6d00731e-ceb9-4b5e-8e65-098b4589b958 591ee107-e953-4982-b75f-13a0afd7c4ae |
Adverse event summaries are temporarily unavailable. Other product information remains available.