FDA label bcb71dc3-3e98-de10-e053-2a95a90a41ac

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
10816e9d-0c53-424b-b482-fdd01a4d8525
SPL ID
bcb71dc3-3e98-de10-e053-2a95a90a41ac
Version
4
Effective date
2022-11-10
Source export date
2026-08-01
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/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:35:28

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 60 minutes get worse need 12 tablets in any day use more than 8 tablets a day for more than 3 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 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. ASK 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 enlargement of the 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 DOCTOR/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 rapid heartbeat you have tremors, nervousness, or seizure cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. 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 PREGNANCY OR BREAST FEEDING ask a health professional before use. KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact Poison Control Center right away.