FDA label b5b3cd42-8f63-4e83-af73-0d53250e127b

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
ea4b9b64-e56a-415c-bd1a-0294cc29cc7c
SPL ID
b5b3cd42-8f63-4e83-af73-0d53250e127b
Version
2
Effective date
2017-11-26
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 01:26:13

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 you take • more than 8 softgels in 24 hours (Nighttime) or more than 12 softgels in 24 hours (Daytime), which is the maximum daily amount • with other drugs containing acetaminophen • 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 • heart disease (DAYTIME ONLY) • thyroid disease (DAYTIME ONLY) • diabetes (DAYTIME ONLY) • high blood pressure (DAYTIME ONLY) • cough that occurs with too much phlegm (mucus) • liver disease • persistent or chronic cough as occurs with smoking, asthma or emphysema • trouble urinating due to an enlarged prostate gland • glaucoma (NIGHTTIME ONLY) • a breathing problem such as emphysema or chronic bronchitis (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: • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if • you get nervous, dizzy or sleepless (DAYTIME ONLY) • redness or swelling is present • fever gets worse or lasts more than 3 days • new symptoms occur • pain, nasal congestion or cough gets worse or lasts more than 7 days • 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. (1-800-222-1222) 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.