FDA label df75f3b2-9a6f-dfb8-e053-2a95a90a04a0

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)

SPL set ID
ad6408ff-079b-4757-e053-2995a90a53eb
SPL ID
df75f3b2-9a6f-dfb8-e053-2a95a90a04a0
Version
6
Effective date
2022-05-20
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 05:23:32

Warnings cross-check#

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

Warnings sections page 1 of 1 · 4 matching rows.

warnings

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skine reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly. Do not use with any drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI, asl a doctor or pharmacist before taking this product. for more than 7 days for pain and 3 days or fever, unless directed by a doctor. Ask a doctor before use if you have liver disease heart disease high blood pressure throid disease diabetes trouble urinating due to enlarged prostate gland a cough that is accompained by excessive phlegm (mucus) a persistant or chronic cough such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin 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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

warnings

Allergy alert: Acetaminophen may cause severe skine reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away

warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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