OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 500 mg
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets 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
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.
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
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptom occur
redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children.
temporarily relieves minor aches and pains
temporarily reduces fever
TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
store at 20⁰C-25⁰C (68⁰F-77⁰F)
for institutional use only
povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben
KEEP OUT OF REACH OF CHILDREN
do not take more than directed
adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
children under 12 years: do not use
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-271-50 | EA - Each | 61919-271 | 8de7b20a-fe91-4458-b745-778dfca3090e | 1 | 2019-09-05 |
| 61919-271-60 | EA - Each | 61919-271 | 28f6a524-c41b-4931-ac82-7348ce3eb73e | 1 | 2019-09-05 |
| 61919-271-71 | EA - Each | 61919-271 | 6d473524-789f-4627-8184-efca2cccd24e | 1 | 2019-09-05 |
| 57896-201-01 | EA - Each | 57896-201 | 82dbdfae-7cce-45e7-bf0c-c214686bb896 | 1 | 2012-07-24 |
| 57896-201-05 | EA - Each | 57896-201 | 5d0770cd-70c2-4757-896d-62e868f751c0 | 1 | 2022-06-06 |
| 57896-201-10 | EA - Each | 57896-201 | aa5f4c60-e670-45f2-861b-c2ad8e686e2a | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61919-271 | 61919-271-71 |
| 57896-201 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| CROSPOVIDONE (15 MPA.S AT 5%) | 68401960MK | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | 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 |
|---|---|---|---|---|---|---|
| Extra Strength Pain Relief | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7570aaa2-3238-4cd3-b788-915caa970dba | 2025-12-04 | Warnings | 57896-201 |
| 074a0bcd-da35-7514-e063-6394a90a6d4a | 8ee83e3a-e8e2-1709-e053-2995a90a7cdd | 2023-10-09 | Warnings | 8ee83e3a-e8e2-1709-e053-2995a90a7cdd |
Adverse event summaries are temporarily unavailable. Other product information remains available.