FDA label e897dffe-cd87-447c-9915-c2cda0a48903

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
fc1acb1d-81bd-4ccf-9a43-61e697cce15d
SPL ID
e897dffe-cd87-447c-9915-c2cda0a48903
Version
3
Effective date
2019-10-07
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 06:12:10

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 Asthma alert Because asthma may be life threatening, see a doctor if you: • Are not better in 20 minutes • Get worse • Need more than 12 inhalations in 24 hours • Use more than 9 inhalations 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. 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 a MAOI, ask a doctor or pharmacist before taking this product. • If product is brown in color or cloudy 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 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). Stop use and ask a doctor if: • Your asthma is getting worse (See Asthma alert ) • You have difficulty sleeping • You have a rapid heartbeat • You have tremors, nervousness, or seizure 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 claimed to have a stimulant effect. • If pregnant or breast-feeding, ask a health professional before use. • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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