FDA label 2f476469-bf57-0fe1-e054-00144ff8d46c

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
fc99da1f-5ce7-4bc4-b6b5-09020cbdac64
SPL ID
2f476469-bf57-0fe1-e054-00144ff8d46c
Version
7
Effective date
2016-03-31
Source export date
2026-08-01
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:25:39

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 6 packets 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. Allergy 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 physician promptly. Do not use: - In a child under 4 years of age. - If you are allergic to acetaminophen. - with any other drug containing acetaminophen (prescription and 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 - high blood pressure - thyroid disease - diabetes - glaucoma - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - 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 - the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - may cause drowsiness - 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 - nervousness, dizziness, or sleeplessness occur - 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 - new symptoms occur 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.