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
LEADER/ Cardinal Health 110, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d
SPL ID
56bd09ea-9506-021f-e063-6394a90a62f0
Version
9
Effective date
2026-07-16
Source export date
2026-08-08
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/1742e81476d3d6cada20c9e3894391dc6e407b1d0da716d0da13f6f74451bfd1/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:56:04
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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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 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 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.