FDA label c24cba3f-de74-5018-e053-2a95a90a9ec8

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
443cae67-37db-418b-b3b3-a543a2aa0e5e
SPL ID
c24cba3f-de74-5018-e053-2a95a90a9ec8
Version
3
Effective date
2021-05-14
Source export date
2026-09-28
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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:16

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 -This product contains acetaminophen; Sever liver damage may occur if you take •more than 4000mg of acetaminophen in 24 hours with •other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this product. Allergy alert: Acetaminophen may cause sever skin reactions. Symptoms may include: •skin reddening •blisters •rash •If 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 a fever, headache, rash, nausea or vomiting, consult a doctor promptly Do not use lf you have ever had an allergic reaction to this product or any of its ingredients •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 MAOI, ask a doctor or pharmacist before taking this product. Ask doctor before use if you have •liver disease •heart disease •high blood pressure •thyroid disease •diabetes •glaucoma •trouble urinating due to enlarged prostate gland •cough that occurs with too much phlegm (mucus) •a breathing problem such as emphysema or chronic bronchitis •cough that lasts or is chronic such as occurs with smoking, asthma or emphysema •a sodium restricted diet. Ask a doctor or pharmacist before use if you are •taking sedatives or tranquilizers •taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage •avoid alcoholic drinks •marked drowsiness may occur •alcohol, sedatives and tranquilizers may increase drowsiness •be careful when driving a motor vehicle or operating machinery •excitability may occur, especially in children. Stop use and ask a doctor if •new symptoms occur •nervousness, dizziness, or sleeplessness occurs •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur •pain, cough or nasal congestion gets worse or lasts more than 7 days •cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Overdose warning. In case of overdose, get medical help or contact a Poison Control Center right away (1 800 222-1222).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.