Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
do not take more than directed (see overdose warning) adults & children 12 years and over: take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets 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 between 20-25°C (68-77°F)
| Active ingredient (in each tablet) | Purpose |
| Acetaminophen USP, 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:
If a skin reaction occurs, stop use and seek medical help right away.
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
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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.
children under 12 years: ask a doctor
Inactive ingredients croscarmellose sodium, hypromellose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid
Questions or comments? call 844-508-1455, 8:00 am - 6:00 pm CT, Monday - Friday
NDC 69584-012-90
EXTRA STRENGTH
ACETAMINOPHEN
TABETS, USP
500 mg
Pain Reliever/Fever Reducer
1000 TABLETS
OXFORD PHARMACEUTICALS, LLC
Important: Read all product information before using.
TAMPER EVIDENT: DO NOT USE IF THE FOIL INNER SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
8000011 Rev. 05/2020 R02
MANUFACTURED BY:
OXFORD PHARMACEUTICALS, LLC
BIRMINGHAM, AL 35211

Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69584-012 | 69584-012-10, 69584-012-90 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Croscarmellose Sodium | M28OL1HH48 | IACT |
| Hypromellose, Unspecified | 3NXW29V3WO | IACT |
| Polyethylene Glycol, Unspecified | 3WJQ0SDW1A | IACT |
| Povidone, Unspecified | FZ989GH94E | IACT |
| Starch, Corn | O8232NY3SJ | IACT |
| Stearic Acid | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| 45086f51-6e63-4aa6-b7ac-ed7dc8d0b1b6 | e0e8fd41-5f6f-46d2-bf38-27a4177afd1e | 2020-09-01 | Warnings | e0e8fd41-5f6f-46d2-bf38-27a4177afd1e |
Adverse event summaries are temporarily unavailable. Other product information remains available.