FDA label 6eeb2d1e-92a2-4d0c-9b69-76706cb040bc

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
966481cb-7352-4e99-b5a3-67c80947acda
SPL ID
6eeb2d1e-92a2-4d0c-9b69-76706cb040bc
Version
2
Effective date
2018-10-19
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 05:16:16

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: These products contain acetaminophen. Severe liver damage may occur if: • adult takes more than 4 doses in 24 hours (Nighttime) or more than 6 doses in 24 hours (Daytime), which is the maximum daily amount • child takes more than 5 doses in 24 hours (Daytime) • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day while using these products Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). 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. • to make a child sleepy Ask a doctor before use if you have • high blood pressure (Daytime only) • heart disease (Daytime only) • diabetes (Daytime only) • thyroid disease (Daytime only) • trouble urinating due to an enlarged prostate gland • liver disease • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma or emphysema • a breathing problem such as emphysema or chronic bronchitis (Nighttime only) • glaucoma (Nighttime only) • a sodium-restricted diet (Nighttime only) Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using these products • do not use more than directed In addition, when using Nighttime: • avoid alcoholic drinks • marked drowsiness may occur • excitability may occur, especially in children • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • you get nervous, dizzy or sleepless (Daytime only) • new symptoms occur • fever gets worse or lasts more than 3 days • redness or swelling is present • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. 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 Center right away. Quick 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.