■ do not use 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 8 caplets in 24 hours, unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor. ■ children under 12 years: ask a doctor
■ store between 20º-25ºC (68º-77ºF)
Acetaminophen 500 mg
Pain reliever/fever reducer
temporary relief of minor aches and pains associated with ■ common cold ■ headache ■ toothache ■ muscular aches ■ backache ■ arthritis ■ menstrual cramps ■ and reduction of fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount 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:
If a skin reaction occurs, stop use and seek medical help right away
liver disease
are taking the blood thinning drug warfarin
ask a health professional before use.
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get help or contact a Poison Control Center (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.
■ do not use 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 8 caplets in 24 hours, unless directed by
a doctor ■ do not take for more than 10 days unless directed by a doctor.
■ children under 12 years: ask a doctor
■ do not use if imprinted safety seal under cap is broken or missing
■ store between 20º-25ºC (68º-77ºF)
corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50804-328 | 50804-328-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | 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 |
|---|---|---|---|---|---|---|
| 570321ec-6b67-4a37-ba51-26c5055896ee | 3168ccdc-bcd1-43fe-9781-07991191e96b | 2021-04-28 | Warnings | 570321ec-6b67-4a37-ba51-26c5055896ee 3168ccdc-bcd1-43fe-9781-07991191e96b |
Adverse event summaries are temporarily unavailable. Other product information remains available.