Indications and uses
For the temporary relief of minor aches and pains associated with: headache muscular aches minor arthritis pain menstrual cramps common cold backaches toothaches temporarily reduces fever
For the temporary relief of minor aches and pains associated with: headache muscular aches minor arthritis pain menstrual cramps common cold backaches toothaches temporarily reduces fever
do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 tablets every 4-6 hours as needed. Do not take more than 12 tablets in 24 hours, unless directed by a doctor. children ages 6-11: take 1 tablet every 4-6 hours as needed. Do not take more than 6 tablets in 24 hours, unless directed by a doctor. under 6 years of age: ask a doctor.
Acetaminophen 500 mg
Pain reliever/Fever reducer
For the temporary relief of minor aches and pains associated with:
temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take more than 12 tablets in 24 hours, with other drugs containing acetaminophen, 3 or more alcoholic drinks every day.
you have liver disease
you are taking the blood thinning drug warfarin
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.
magnesium stearate, povidone, silicon dioxide, sodium carboxymethyl starch, starch, stearic acid
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53145-830 | 53145-830-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SODIUM CARBOXYMETHYL STARCH | H8AV0SQX4D | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| POVIDONE | FZ989GH94E | 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 |
|---|---|---|---|---|---|---|
| Duralgina Extra Strength | ACETAMINOPHEN | Menper Distributors, Inc. | 544e3d7e-a759-384f-e063-6294a90a5baa | 2026-06-15 | Warnings | 53145-830-30 53145-830 53145083030 544e3d7e-a75a-384f-e063-6294a90a5baa 544e3d7e-a759-384f-e063-6294a90a5baa |
Adverse event summaries are temporarily unavailable. Other product information remains available.