Storage and handling
Other information Store at room temperature
Other information Store at room temperature
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purposes
Pain Reliever/Fever Reducer
Uses
Warnings
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:
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
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 the 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.
Directions
adults and children 12 years and over:
children under 12 years: ask a doctor
Other information
Inactive ingredients Hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments? Call (800) 616-2471
Do not use if imprinted safety seal under cap is broken or missing
Distributed By: MAJOR® PHARMACEUTICALS
17177 N. Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-1983-24 | EA - Each | 0904-1983 | df85e3a7-30ff-44ed-a264-5fa1e63181a1 | 1 | 2012-07-24 |
| 0904-1983-40 | EA - Each | 0904-1983 | ee76b870-680e-4a70-acf0-cd96d6c36cc9 | 1 | 2012-07-24 |
| 0904-1983-51 | EA - Each | 0904-1983 | 6a7143a5-4d2d-4a4f-a0fe-42f0cc8f1bf9 | 1 | 2012-07-24 |
| 0904-1983-59 | EA - Each | 0904-1983 | ae8ae308-2bba-4cbe-b1eb-a24aa7b6d5b3 | 1 | 2012-07-24 |
| 0904-1983-60 | EA - Each | 0904-1983 | 6313c245-3577-40fb-9237-6dddba21ef56 | 1 | 2012-07-24 |
| 0904-1983-80 | EA - Each | 0904-1983 | 331f08d8-67e9-4269-a4f5-75c9df7afcfa | 1 | 2012-07-24 |
| 0904-1983-94 | EA - Each | 0904-1983 | 75869f66-6326-4a80-9c4c-aab1ff80abe5 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68071-4107 | 68071-4107-3, 68071-4107-4, 68071-4107-9 |
| 0904-1983 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| a6905176-85b0-15c5-e053-2995a90aaf85 | 5b4e1ea0-d65e-6929-e053-2991aa0a626e | 2020-05-26 | Warnings | 5b4e1ea0-d65e-6929-e053-2991aa0a626e |
Adverse event summaries are temporarily unavailable. Other product information remains available.