Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
do not take more than directed (see overdose warning) adults and take 2 gelcaps every 6 hours while symptoms last children 12 years and over do not take more than 6 gelcaps 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 at 20°-25°C (68°-77°F) avoid high humidity see end panel for expiration date and lot number
Acetaminophen USP, 500 mg
Pain reliever/fever reducer
temporarily relieves minor aches and pains due to:
headache muscular aches
backache minor pain of arthritis
the common cold toothache
premenstrual and menstrual cramps
temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
skin reddening blisters rash
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
Keep out of reach of children
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.
do not take more than directed (see overdose warning)
adults and take 2 gelcaps every 6 hours while symptoms last
children 12 years
and over do not take more than 6 gelcaps 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 at 20°-25°C (68°-77°F)
avoid high humidity
see end panel for expiration date and lot number
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red
#40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene
glycol, povidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide,
yellow iron oxide
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 79481-1670 | 79481-1670-1, 79481-1670-2, 79481-1670-4 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-12-19 | full-release | 2026-06-01 01:27:07 |
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 |
|---|---|---|---|---|---|---|
| 5579b325-4cd0-f9af-e063-6294a90a8f5b | 181aee35-8fb2-35e4-e063-6394a90a6b3b | 2026-06-30 | Warnings | 5579b325-4cd0-f9af-e063-6294a90a8f5b 181aee35-8fb2-35e4-e063-6394a90a6b3b |
Adverse event summaries are temporarily unavailable. Other product information remains available.