FDA label 201f2b0f-8a8d-b9f0-e063-6394a90aedc5

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
1ad0cb11-9a58-2b56-e063-6294a90a79fd
SPL ID
201f2b0f-8a8d-b9f0-e063-6394a90aedc5
Version
3
Effective date
2024-08-20
Source export date
2026-08-01
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/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:13:47

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 12 tablets in 24 hours , which is the maximum daily amount for this product 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, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your 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 a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed the recommended dosage may cause drowsiness may cause excitability, especially in children avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain or nasal congestion persists for more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of an accidental 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.