FDA label fb2cad6f-707b-4e89-80f9-9c155bc7bff6

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
390a0c89-a640-4a0b-aaf3-955b502fb33a
SPL ID
fb2cad6f-707b-4e89-80f9-9c155bc7bff6
Version
2
Effective date
2010-07-26
Source export date
2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:49

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 Alcohol Warnings : if you consume 3 or more alcoholic drinks every day, ask you doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever,headache,rash,nausea or vomiting, consult a doctor promptly. Do not use with other medicines containing acetaminophen 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 Glaucoma thyroid disease trouble urinating due to enlarged postage gland cough that occurs with too much phlegm(mucus) A breathing problem or chronic, cough that lasts or as occurs with smoking,asthma,chronic,bronchitis or emphysema Ask a doctor or pharmacists before use if you are taking sedatives or tranquilizers. when using this product do not use more than directed excitability may occur , especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness Stop use and ask doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or less tan 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious conditions If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children . Overdose Warning : Taking more than the recommended dose 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 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.