Indications
Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Warnings and precautions
Warnings Allergy alert:
- Do not use if you are allergic to omeprazole.
- Omeprazole may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If an allergic reaction occurs, stop use and seek medical help right away.
Pregnancy and breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Composition
- Active ingredients
- OMEPRAZOLE MAGNESIUM EQ 20MG BASE
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021229.
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
- Prilosec OTC
- Active substance
- omeprazole magnesium
- Route
- Oral
- Dosage form
- Tablet, delayed release
- Applicant
- Astrazeneca
- Status
- Over the counter
- FDA approval
- 20 Jun 2003
- Application
- NDA021229-001