FDA label ecee51ba-e314-4710-913f-9100219da8ce

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
f8c1f2b7-8b1b-49f2-a774-b3a38d31b10e
SPL ID
ecee51ba-e314-4710-913f-9100219da8ce
Version
4
Effective date
2026-06-22
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:28:54

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 adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening 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 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 have ever had an allergic reaction to this product or any of its ingredients to make a child sleepy Ask a doctor before use if the user has difficulty in urination due to enlargement of the prostate gland liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if the user is taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children avoid alcoholic beverages Stop use and ask a doctor if pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults) new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.