Category
Heartburn medications and what the FDA label actually says
5 medications9 FDA labels4 comparisons
Heartburn is the one area in this catalogue where the same medicine routinely holds two FDA approvals at once: one for a product sold off the shelf, another for the prescription version. Omeprazole, esomeprazole and lansoprazole each have both, and the two documents are not abridged versions of one another.
The split is not between conditions but between decisions. An over-the-counter label authorises a 14-day course for frequent heartburn in adults and says when to stop and see a doctor. The prescription label of the same ingredient covers ulcers, reflux disease and erosive oesophagitis, sets a duration per indication, and spells out the class warnings at length.
Nothing here is a recommendation. Persistent heartburn is a reason to see a clinician, and every label on these pages says so in its own words.
FDA approvals and boxed warnings across this category
Built from the 9 labels linked on the pages below, so it cannot drift from them. A boxed warning is the strongest warning the FDA requires, and where several medications carry the same one, it belongs to the class rather than to the product.
| Medication | Class | Approved for heartburn | Boxed warning | Supply |
|---|---|---|---|---|
| OmeprazolePrilosec OTC, Omeprazole delayed-release capsules | Proton pump inhibitor | Yes | None | Both |
| EsomeprazoleNexium, Nexium 24HR | Proton pump inhibitor | Yes | None | Both |
| LansoprazolePrevacid, Prevacid 24 HR | Proton pump inhibitor | Yes | None | Both |
| PantoprazoleProtonix | Proton pump inhibitor | Yes | None | Prescription |
| FamotidinePepcid AC, Famotidine tablets | Histamine-2 receptor antagonist | Yes | None | Both |
Two labels, side by side
- NexiumvsNexium 24HRNexium and Nexium 24HR are both esomeprazole. One is a prescription medicine for reflux disease and ulcers, the other a 14-day course sold over the counter. From both FDA labels.
- Prilosec OTCvsNexium 24HRPrilosec OTC is omeprazole, Nexium 24HR is esomeprazole. Both are 20 mg, once daily, for 14 days. What the FDA labels say about the difference, and what they do not.
- Pepcid ACvsPrilosec OTCPepcid AC is famotidine, Prilosec OTC is omeprazole. One label allows taking it before a meal to prevent heartburn, the other describes a 14-day course. Straight from both.
- ProtonixvsOmeprazole delayed-release capsulesProtonix is pantoprazole, prescription only. Omeprazole is prescription and also sold over the counter. What each FDA label approves, and where the lists diverge.
Approved by the FDA for heartburn
Each of these has at least one FDA approval covering this use.
- OmeprazoleApproved for heartburnOver the counter
Proton pump inhibitor. Sold as Prilosec OTC, Omeprazole delayed-release capsules.
Omeprazole is sold both over the counter as Prilosec OTC and on prescription as a generic capsule. The two are described by different documents: the shop version is approved for a 14-day course against frequent heartburn, the prescription one for duodenal and gastric ulcers, GERD and erosive oesophagitis.
- EsomeprazoleApproved for heartburnOver the counter
Proton pump inhibitor. Sold as Nexium, Nexium 24HR.
Esomeprazole is sold as prescription Nexium and over the counter as Nexium 24HR. The prescription label runs from erosive oesophagitis and H. pylori eradication down to infants of one month; the shop label covers a 14-day course for adults with frequent heartburn.
- LansoprazoleApproved for heartburnOver the counter
Proton pump inhibitor. Sold as Prevacid, Prevacid 24 HR.
Lansoprazole is prescription Prevacid and over-the-counter Prevacid 24 HR. It is the one in this group where the two forms differ in strength as well as in status: the shop capsule is 15 mg, and the prescription product is supplied at 30 mg alongside an orally disintegrating tablet.
- PantoprazoleApproved for heartburn
Proton pump inhibitor. Sold as Protonix.
Pantoprazole is sold as Protonix and has no over-the-counter version in the United States. Its label is narrower than the others here: erosive oesophagitis associated with GERD, maintenance of that healing, and pathological hypersecretory conditions.
- FamotidineApproved for heartburnOver the counter
Histamine-2 receptor antagonist. Sold as Pepcid AC, Famotidine tablets.
Famotidine is the one medicine in this category that is not a proton pump inhibitor. It is sold over the counter as Pepcid AC and on prescription as tablets, and its label allows something no proton pump inhibitor label here does: taking it in advance, to prevent heartburn rather than to treat it.