FDA label 2851d545-6937-e3c8-e063-6394a90a7461

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
e338deef-efad-1d82-e053-2995a90a1bf9
SPL ID
2851d545-6937-e3c8-e063-6394a90a7461
Version
3
Effective date
2024-12-02
Source export date
2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:28:43

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 6 caplets in 24 hours  use more than 4 caplets 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 asthma 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 taken 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.  if you have ever had an allergic reaction to this product or any of its ingredients 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) 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 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 seizure 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.