FDA label 28c4fcc2-0a53-1752-e054-00144ff8d46c

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
7047e4b8-d111-4540-89e0-5f29dc17a03d
SPL ID
28c4fcc2-0a53-1752-e054-00144ff8d46c
Version
2
Effective date
2016-01-07
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:16:47

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 6 packets 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. Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. - with any other product containing acetaminophen (see Overdose Warning). Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - glaucoma - a breathing problem such as emphysema, asthma, or chronic bronchitis - trouble urinating due to an enlarged prostate gland - a sodium-restricted diet. Ask a doctor or pharmacist before use if you are taking - sedatives or tranquilizers - the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - may cause drowsiness - alcohol, sedatives, and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occur - pain or nasal congestion gets worse or lasts more than 7 days - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Overdose Warning: Taking more than the recommended dose can cause serious health problems, including serious liver damage. In case of 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.

Reported adverse events (FAERS/openFDA)#

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