Acetaminophen

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Acetaminophen
Generic name
ACETAMINOPHEN
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
64696f65-415e-4ce1-a5b3-70662fbcb002
SPL ID
48390181-cda8-a543-e063-6294a90a5896
Version
17
Effective date
2026-01-12
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:58
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 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 redness or swelling is present new symptoms occur 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 don't notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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