FDA label 1996a975-941f-4b62-85e6-dcb03be6df86

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
b135decd-be2d-48e5-bbe4-817e872ab716
SPL ID
1996a975-941f-4b62-85e6-dcb03be6df86
Version
8
Effective date
2025-06-11
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:52

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. Severe liver damage may occur if you take: adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 mL each) in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product. Allery alert: Acetaminophen 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: 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 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if the user has liver disease heart disease thyroid disease diabetes high blood pressure a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage . Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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.