FDA label 240453b0-189a-401e-9f2e-2bf977f7aaa6

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
8600db56-a877-4557-ab71-d46b72d642c9
SPL ID
240453b0-189a-401e-9f2e-2bf977f7aaa6
Version
1
Effective date
2014-08-24
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 05:22:19

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 8 tablets in 24 hours which is maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat waring: If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Do not use to sedate children. do not use: with any other drug containing acetaminophen (prescription or not prescription). 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 drug, If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease Heart disease Thyroid disease Diabetes High blood pressure Glaucoma Cough with excessive phlegm (mucus) A breathing problem such as emphysema or chronic bronchitis Difficulty in urinating due to enlargement of prostate gland Persistent or chronic cough such as occurs with smoking, asthma or emphysema A sodium restricted diet ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. taking sedative or tranquilizers when using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedative 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 pain, cough 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 cough comes back or occurs with rash or headache that lasts. These could be signs of serious condition. Nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use

Reported adverse events (FAERS/openFDA)#

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