FDA label 8f3be3b2-b2de-4043-a3c0-620e16dc475a

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
2ef6f418-53fb-4fd5-ab91-85a0d6a60f83
SPL ID
8f3be3b2-b2de-4043-a3c0-620e16dc475a
Version
3
Effective date
2011-09-20
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 01:26:27

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 8 caplets 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 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, ask a doctor promptly Do not use with another 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. Ask a doctor before use if you have liver disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis heart disease diabetes glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin sedatives or tranquilizers When using this product do not exceed recommended dosage drowsiness may occur avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness effect be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present you get nervous, dizzy, or sleepless new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact 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.