FDA label 5b4d3e49-e47d-4eaa-aac8-ce84a31a043d

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
0f0f6488-0366-4bdf-ad49-cdbdced9d0c9
SPL ID
5b4d3e49-e47d-4eaa-aac8-ce84a31a043d
Version
3
Effective date
2021-06-11
Source export date
2026-08-01
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:12:02

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 Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 doses in 24 hours, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy Alert: If you have ever experienced allergic reactions induced by drugs. Symptoms may include: • Skin reddening • Blisters • Rash If a skin reaction occurs, stop use and seek medical help right away. 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. Reye’s syndrome: a chickenpox or influenza-suspected infant or child under 15 years of age If it is accompanied by nausea or vomit, it may be early symptoms of Reye’s syndrome, rare but serious, 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 conditions an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • liver disease • heart disease • renal disease • high blood pressure • thyroid disease • diabetes • glaucoma • dysuria • weak condition • high fever • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, pulmonary emphysema, and excessive sputum production • trouble urinating due to enlarged prostate gland • a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizer • taking blood thinning drug warfarin When using this product • observe usage and dosage instructions. • do not take this drug for a long term. • children should take this drug under the guardians’ supervision. • do not drink alcohol while you are taking this drug. • tends to cause drowsiness, avoid driving cars and operating machinery while taking this drug. • patients, administered with barbital drugs, tricyclic antidepressants, or alcohol, tend to lack the ability to metabolize lots of acetaminophen, their plasma elimination half-life may increase. Stop use and ask a doctor if • cough and pain gets worse or persist for more than a week and accompanied by rash, flare, itching, nausea, vomiting, edema (swelling), dysuria, or insomnia. • fever gets worse or lasts more than 3 days. • new symptoms occur. • cough come back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant, potentially-pregnant, or breast-feeding, ask a health professional before use.