FDA label d203cb84-8ab2-433a-b670-5b264055349b

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
6b79cb3b-9d9e-4ea5-b7a6-bbcd07471d2a
SPL ID
d203cb84-8ab2-433a-b670-5b264055349b
Version
3
Effective date
2022-01-05
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:24:23

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 • 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 that directed Stop use and ask a doctor if • cough lasts more than 7 days comes back or occurs with fever, rash or headache that lasts. These could be sings of a serious condition. If pregnancy 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 older: 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 • low sodium • store at room temperature • do not refrigerate

Reported adverse events (FAERS/openFDA)#

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