FDA label 4549fc56-ac5a-1a7c-e063-6294a90a2570

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
7650c4bc-9dad-dde0-e053-2a91aa0aa20b
SPL ID
4549fc56-ac5a-1a7c-e063-6294a90a2570
Version
4
Effective date
2025-12-06
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:43:08

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: Daytime & Nighttime This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen Daytime & Nighttime may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: Daytime & Nighttime 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 Daytime & Nighttime 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. for more than 3 days for fever, unless directed by a doctor Ask a doctor before use if you have Daytime liver disease heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm(mucus) a persistent or chronic cough as occurs with smoking, asthma, or emphysema trouble urinating due to enlarged prostate gland Nighttime liver disease glaucoma a cough that is accompanied by excessive phlegm (mucus) a breathing problem, persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are Daytime taking the blood thinning drug warfarin Nighttime taking sedatives or tranquilizers taking bloodthinning drug warfarin Stop use and ask a doctor if Daytime symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. new symptoms occur redness or swelling is present nervousness, dizziness, or sleeplessness occur.These could be signs of a serious condition. Nighttime pain or cough gets worse or lasts more than 5 days redness or swelling is present new symptoms occur cough comes back, occurs with rash or a persistent headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, Daytime & Nighttime ask a health professional before use. Keep out of reach of children. Daytime & Nighttime In case of accidental 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.

Reported adverse events (FAERS/openFDA)#

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