Primatene

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)

Brand name
Primatene
Generic name
EPHEDRINE HYDROCHLORIDE
Manufacturer
Foundation Consumer Brands
Product type
HUMAN OTC DRUG
SPL set ID
2170f081-c03f-47e8-bc63-4052c5e653fa
SPL ID
2657d074-46cb-bc95-e063-6294a90aeec8
Version
2
Effective date
2024-11-07
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:32:54
Harmonized routes table
Harmonized routes
ORAL

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 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 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.