FDA label c863b9be-68be-404d-8a21-16237bbcf43e

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
f142eec2-1764-4086-b24e-fbff358ed8df
SPL ID
c863b9be-68be-404d-8a21-16237bbcf43e
Version
6
Effective date
2013-01-25
Source export date
2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:13:23

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 DO NOT USE THIS PRODUCT TO SEDATE CHILDREN Liver warning: This product contains acetaminophne. Severe liver damange may occur if you take: more than 4 doses 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. 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 monoamie 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 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. a breathing problem such as emphysema, asthma or chronic broncititis. trouble uritinating due to an enlarged prostate gland. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin. When using this product do not use more than directed. avoid alcoholic drinks. drowsiness may occur. 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 you get nervous, dizzy or sleepless. 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. sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. If pregnant or breast-feeding, Do Not Use Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as 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.