ACETAMINOPHEN
- Manufacturer
- Direct_Rx
- Effective date
- 2023-07-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:28:28
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Pain Reliever/Fever Reducer
OTC - WHEN USING SECTION
temporarily relieves minor aches and pains
temporarily reduces fever
WARNINGS SECTION
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
more than 8 tablets (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.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use..
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. 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.
OTC - QUESTIONS SECTION
1-800-540-3765
INACTIVE INGREDIENT SECTION
povidone, sodium starch glycolate, starch, stearic acid.
DOSAGE & ADMINISTRATION SECTION
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 6 tablets in 24 hours. Do
not take for more than 10 days unless directed by a doctor.
children under 12 years: ask a doctor
INDICATIONS & USAGE SECTION
Pain Reliever/Fever Reducer
temporarily relieves minor aches and pains
temporarily reduces fever
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-413-30 | EA - Each | 72189-413 | 976b7068-552e-4b4d-97e2-4cb76d6dd4b4 | 1 | 2023-02-06 |
| 57896-204-01 | EA - Each | 57896-204 | 5b5981d9-4c39-4d62-9bb3-1944ee83a128 | 1 | 2018-12-13 |
| 57896-204-05 | EA - Each | 57896-204 | 0ef19d63-6981-46b8-a80e-e204eb7dc370 | 1 | 2021-06-02 |
| 57896-204-20 | EA - Each | 57896-204 | a4fc79ba-8933-4ac1-9056-046d8a6d1c3b | 1 | 2022-03-09 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- STEARIC ACID
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-413 | 72189-413-30 |
| 57896-204 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| POVIDONE | FZ989GH94E | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7a29dde6-a177-6206-e053-2991aa0a01f2 | 2025-12-04 | Warnings | 57896-204 |
| 074cbd37-1452-7d3b-e063-6294a90a340f | f28bb4d2-d57f-1a62-e053-2995a90aa0c6 | 2023-10-09 | Warnings | f28bb4d2-d57f-1a62-e053-2995a90aa0c6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
