FDA label 02505212-2247-4de8-866d-fe5ac88ee6b2

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
569cfe1e-a9ed-4c85-94e7-1f42d5b1897a
SPL ID
02505212-2247-4de8-866d-fe5ac88ee6b2
Version
1
Effective date
2014-08-27
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:02:22

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

[DO NOT USE] if you are hypersensitive to this drug and any component of this drug if you have a history of asthma after taking this drug, other cold drugs or antipyreticanalgesics in infants under 3 months of age 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 with antitussive expectorants, other cold medicines, antipyretic-analgesics, sedatives, antihistamines(certain drugs for rhinitis, preventive drugs for travel sickness, allergies) [ASK A DOCTOR OR PHARMACIST BEFORE USE] in infants or children under 15 years infected with chickenpox or influenza in infants under 2 years of age only when it is necessary. Inform to the guardian/s and monitor closely while administering if you are genetically prone to uticaria, contact dermatitis, bronchial asthma, allergic rhinitis, migraine, food allergy If you have allergic reactions (e.g., fever, rash, arthralgia, asthma, itch, etc.) to this drug and any component of this drug if you have liver disease, kidney disease, heart disease, thyroid disease, diabetes, high blood pressure, edema, stomach-duodenal ulcer, glaucoma, dysuria, high fever if you are elderly or week if you have bleeding , ache and discomfort in stomach If (possibly) pregnant or breast-feeding If you are taking a prescription drug for diabetes, goat, arthritis, anticoagulants and steroids if you have cough by smoking, asthma, chronic bronchitis, emphysema, cough accompanied with excessive sputum, fever, rash, persistent headache and cough lasting more than 1 week, recurrent cough or chronic cough [STOP USE AND ASK A DOCTOR IF] you experience any of the following symptoms: rash, redness, itching, nausea, vomiting, loss of appetite, constipation, edema, dysuria, severe or persistent thirst, dizziness, anxiety, shivering, insomnia you experience any of the following severe symptoms: anaphylaxis (e.g., immediate rash, edema, shortness of breath along with paling of face, cold sweat, cold hands and feet) Stevens-Johnson syndrome (mucocutaneous syndrome) or Lyell syndrome (toxic epidermal necrosis) (e.g., rash and redness accompanied with high fever, blisters as in burn over the body or mucous membranes of mouth or eyes) asthma liver dysfunction (e.g., drowsiness, jaundice) interstitial pneumonia (e.g., shortness of breath, fever accompanied with cough) aldosteronism: long-term continuous use of preparations containing over than 1g as licorice (daily maximum dose) may cause hypokalemia, increased blood pressure, fluid retention of sodium, edema, weight gain, aldosteronism. Observe closely (blood potassium concentration) and stop taking this drug and when you have above symptoms. myopathy may rarely occur as a result of hypokalemia. Observe closely and stop taking this drug when you appear symptoms such as weakness, limb spasms, and numbness. [WHEN USING THIS PRODUCT] do not exceed recommended dosage do not take for a long period of time administer to children under the guidance and supervision of a guardian avoid alcoholic drinks do not drive a motor vehicle or operate machinery barbiturates, tricyclic antidepressants, and alcohol may reduce the ability to metabolize large quantities of acetaminophen, thereby increasing the plasma half-life of acetaminophen myopathy may occur due to aldosteronism or hypokalemia when administered with drugs containing potassium, licorice, glycyrrhizin acid or its salts, loop diuretics (furosemide, ethacrynic acid) or thiazide diuretic (trichlormethiazide).

Reported adverse events (FAERS/openFDA)#

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