FDA
Sudafed 12 Hour
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- PSEUDOEPHEDRINE HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · Tablet, extended releaseANDA073585-001 · Discontinued
- PSEUDOEPHEDRINE HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Capsule, extended releaseThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA017941.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Sudafed 12 Hour
- Active substance
- pseudoephedrine hydrochloride
- Route
- Oral
- Dosage form
- Capsule, extended release
- Applicant
- Glaxosmithkline
- Status
- Discontinued
- Application
- NDA017941-002