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#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure15 sections

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

72189-413-3072189-413-30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-413-30EA - Each72189-413976b7068-552e-4b4d-97e2-4cb76d6dd4b412023-02-06
57896-204-01EA - Each57896-2045b5981d9-4c39-4d62-9bb3-1944ee83a12812018-12-13
57896-204-05EA - Each57896-2040ef19d63-6981-46b8-a80e-e204eb7dc37012021-06-02
57896-204-20EA - Each57896-204a4fc79ba-8933-4ac1-9056-046d8a6d1c3b12022-03-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72189-41372189-413-30
57896-204

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a29dde6-a177-6206-e053-2991aa0a01f22025-12-04WarningsExact identifier
ndc (product): 57896-204
074cbd37-1452-7d3b-e063-6294a90a340ff28bb4d2-d57f-1a62-e053-2995a90aa0c62023-10-09WarningsExact identifier
spl set id: f28bb4d2-d57f-1a62-e053-2995a90aa0c6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.