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
Acetaminophen
- Manufacturer
- TOPCO ASSOCIATES LLC
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:08
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure16 sections
Dosage and administration
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last 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
Storage and handling
store at 20°-25°C (68°-77°F) avoid high humidity see end panel for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each gelcap)
Acetaminophen USP, 500 mg.
Purpose
Pain reliever/fever reducer
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
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
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.
if you are allergic to acetaminophen or any of the inactive ingredients in this product
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 symptoms occur
redness or swelling is present
Drug Facts (continued)
These could be signs of a serious condition
If pregnant or breast-feeding
ask a health professional before use
.
Keep out of reach of children
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
Directions
do not take more than directed (see overdose warning)
adults and children 12 years and over
take 2 gelcaps every 6 hours while symptoms last
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
Other information
store at 20°-25°C (68°-77°F)
avoid high humidity
see end panel for expiration date and lot number
Inactive ingredients
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, p ovidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide
Questions or comments?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-665-10 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 36800-665-21 | Acetaminophen | 225 in 1 BOTTLE | TABLET | 225 | 5 | |
| 36800-665-40 | Acetaminophen | 400 in 1 BOTTLE | TABLET | 400 | 5 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- BUTYL ALCOHOL
- HYDROXYPROPYL CELLULOSE (1600000 WAMW)
- HYDROXYMETHYL CELLULOSE
- FD&C RED NO. 40
- SHELLAC
- FERRIC OXIDE YELLOW
- D&C RED NO. 33
- STARCH, CORN
- AMMONIA
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- GELATIN
- ISOPROPYL ALCOHOL
- TITANIUM DIOXIDE
- POVIDONE K30
- CROSCARMELLOSE SODIUM
- FERRIC OXIDE RED
- HYPROMELLOSE 2910 (3 MPA.S)
- STEARIC ACID
- PROPYLENE GLYCOL
- SILICON DIOXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- FERROSOFERRIC OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-665 | 36800-665-21, 36800-665-10, 36800-665-40 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
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 | TOPCO ASSOCIATES LLC | 1a00a49e-f9ff-b928-e063-6394a90a4cb5 | 2025-12-19 | Warnings | 36800-665-40 36800-665-21 36800-665-10 36800-665 36800066510 36800066540 36800066521 4651f3b4-2e3a-fc6f-e063-6294a90adbba 1a00a49e-f9ff-b928-e063-6394a90a4cb5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.