FDA label d90ee70c-59df-4976-b66b-b8ece17f744a

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
d90ee70c-59df-4976-b66b-b8ece17f744a
SPL ID
d90ee70c-59df-4976-b66b-b8ece17f744a
Version
1
Effective date
2020-04-13
Source export date
2026-11-06
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:07:35

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Do not use • 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 ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ cough that occurs with too much phlegm (mucus) When using this product do not use more than directed If pregnant or breast-feeding ask a health professional before use Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison control Centre right away at 1-800-222-1222

warnings

Warnings Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take\ ▪ more than 4000 mg in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks daily while using this product If pregnant or breast feeding ask a health professional before use Keep Out of Reach of Children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centre right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs Directions ▪ do not take more than directed (see overdose warnings ▪ do not take more than 4 doses in any 24-hour period ▪ measure only with dosing cup provided ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor ▪ adults and children 12 years of age and over: 20 ml in dosing cup provided every 4 hours ▪ children under 12 years of age: do not use Other Information ▪ each 20 mL contains: sodium 10 mg ▪ store at room temperature ▪ do not refrigerate

Reported adverse events (FAERS/openFDA)#

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