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 and children 12 years and over • take 2 softgel every 6 hours while symptoms last •do not take more than 6 softgel 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
Acetaminophen 500 mg
Pain reliever/fever reducer
•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
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.
• with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.
• liver disease
taking the blood thinning drug warfarin
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present.
These could be signs of a serious condition.
ask a health professional before use.
Overdose warnings:
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.
• do not take more than directed (see overdose warning).
| adults and children 12 years and over | • take 2 softgel every 6 hours while symptoms last •do not take more than 6 softgel 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 |
FD&C red 40, gelatin,glycerin, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, povidone K30,purified water, sorbitol sorbitan solution, titanium dioxide
label
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35916-0183 | 35916-0183-2, 35916-0183-3, 35916-0183-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| GELATIN | 2G86QN327L | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| POLYOXYL 40 HYDROGENATED CASTOR OIL | 7YC686GQ8F | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2026-07-16 | daily-update | 2026-07-18 05:11:28 |
| 6 | 2026-04-27 | full-release | 2026-06-01 01:55:04 |
| 5 | 2026-01-13 | monthly-update | 2026-06-03 17:52:45 |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Softgel Healthcare Pvt Ltd | 352bb451-ffdc-411a-e063-6294a90a8cf5 | 2026-07-24 | Warnings | 35916-0183-2 35916-0183-4 35916-0183-3 35916-0183 35916018304 35916018303 35916018302 57593d02-16fb-2611-e063-6294a90ad030 352bb451-ffdc-411a-e063-6294a90a8cf5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.