FDA label 59a17ad9-395b-16b0-e053-2991aa0a9a40

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
1aa6af70-06f3-4427-9378-ff7452277096
SPL ID
59a17ad9-395b-16b0-e053-2991aa0a9a40
Version
6
Effective date
2017-09-20
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:15

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 Warnings Failure to follow these warnings could result in serious consequences. Liver Warning: This product contains acetaminophen . Severe liver damage may occur if you take more than 4 doses 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 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 Trouble urinating due to enlarged prostate gland ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if: Redness or swelling is present You get nervous, dizzy or sleepless Fever gets worse or lasts more than 3 days New symptoms occur Symptoms do not get better within 7 days or are accompanied by a fever NightTime Cold and Flu: Warnings Failure to follow these warnings could result in serious consequences. Liver Warning: This product contains acetaminophen . Severe liver damage may occur if you take more than 4 doses 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 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 Trouble urinating due to enlarged prostate gland ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if: Redness or swelling is present You get nervous, dizzy or sleepless Fever gets worse or lasts more than 3 days New symptoms occur Symptoms do not get better within 7 days or are accompanied by a fever If pregnant or breast-feeding, ask a health professional before use. Overdose warning : Taking more than recommended dose (overdose) may cause 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. Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Reported adverse events (FAERS/openFDA)#

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