Acetaminophen Caplets

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 Caplets
Generic name
ACETAMINOPHEN
Manufacturer
Breeden Brothers, LLC
Product type
HUMAN OTC DRUG
SPL set ID
57fff3dc-ba30-4d3d-9362-01df6974f813
SPL ID
62ddc12d-7480-4db8-a784-e2e1503fad2b
Version
2
Effective date
2017-02-15
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:24:13
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: _ rash _ blisters _ skin reddening If a skin reaction occurs, stop use and seek medical help right away. Do not use _ if you are allergic to acetaminophen or any of the inactive ingredients in this product _ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug Drug Facts (continued) contains acetaminophen, ask a doctor or pharmacist. 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is Drug Facts (continued) critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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