FDA label 49a01d42-ab31-c89c-e063-6294a90aaba7

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
49a01d36-dd5c-1176-e063-6294a90a2c6a
SPL ID
49a01d42-ab31-c89c-e063-6294a90aaba7
Version
1
Effective date
2026-01-30
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:01:46

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: More than 4 doses in 24 hrs, which is the maximum daily amount for this product. With other drugs containing acetaminophen. 3 or more alcoholic drinks daily while using this product. Allergy alert: Acetaminophen may cause severe skin reactions. Symtoms 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, lasts more than 2 days, is accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promplty. 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 contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have Liver disease Heart disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask a doctor or pharmacist before use if you are: Taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if You get nervous, dizzy or sleepless. Symptoms get worse or last more than 5 days (children) or 7 days (adults). Fever gets worse or lasts more than 3 days. Redness or swelling is present. New symtoms occur. Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. Keep out of reach of children. If pregnant or breast-feeding, ask a health professional before use. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well 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.