FDA label f161ce18-10f5-5f51-e053-2a95a90a389f

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
a79609d2-f125-40a8-ac86-0ad98589b0fb
SPL ID
f161ce18-10f5-5f51-e053-2a95a90a389f
Version
3
Effective date
2023-01-03
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:54

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

Asthma Alert: because asthma may be life threatening, see a doctor if you: • Are not better in 60 minutes • get worse • need more than 12 tablets in 24 hours • use more than 8 tablets in 24 hours for 3 or more days a week • have more than 2 asthma attacks in a week. These may be signs that your asthma is getting worse. This product will not give you relief as quickly as an inhaled bronchodilator Do not use: • Unless a doctor said you have asthma • 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: • ever been hospitalized for asthma • heart disease • high blood pressure • diabetes • thyroid disease • seizures • narrow angle glaucoma • a psychiatric or emotional condition • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema. Ask a doctor or pharmacist before use if you are: • taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions. Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain) When using this product • your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. • your risk of heart attack or stroke increases if you:• have a history of high blood pressure or heart disease • take this product more frequently or take more than the recommended dose. • avoid foods or beverages that contain caffeine • Avoid dietary supplements containing ingredients reported or claim to have a stimulant effect. Stop use and ask a doctor if: • your asthma is getting worse (see Asthma alert) • you have difficulty sleeping • you have a rapid heart beat • you have tremors, nervousness or seizures • cough lasts more than 1 week, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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