HeartburnActive ingredient
Lansoprazole
Proton pump inhibitor2 FDA labels read
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.
Highlights of the labels
- Prevacid
- GERD, erosive esophagitis, ulcerscovers heartburn
- Prevacid 24 HR
- Frequent heartburn, as a 14-day coursecovers heartburn
- Supply
- Some brands prescription, some over the counter
- Generic
- 19 approved applications
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| PrevacidTakeda Pharmaceuticals America, Inc. | What its label approvesGERD, erosive esophagitis, ulcersCovers heartburn | SupplyPrescription | Label version8 July 2025 |
| Prevacid 24 HRL. Perrigo Company | What its label approvesFrequent heartburn, as a 14-day courseCovers heartburn | SupplyOver the counter | Label version24 June 2025 |
How it works
The prescription label is where the class warnings are set out at length: kidney inflammation, Clostridium difficile diarrhea, fractures with long-term use. The over-the-counter label of the same ingredient carries none of that detail and instead tells the reader when to stop and see a doctor. Same molecule, two registers of writing.
Mechanism of action, Prevacid label
Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H +, K +)-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.
What the FDA approved it for
The approved uses, as worded in the label.
Prevacid
- PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults.
- Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults.
- Maintenance of healed duodenal ulcers in adults.
- Treatment of active benign gastric ulcer in adults.
- Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults.
- Risk reduction of NSAID-associated gastric ulcer in adults.
Prevacid 24 HR
- Acid Reducer
- • 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
Forms and strengths
The presentations and strengths listed in the label.
Prevacid
- PREVACID delayed-release capsules: 15 mg strength is not currently marketed by Takeda Pharmaceuticals America, Inc. 30 mg strength is an opaque, pink and black capsule imprinted with "TAP" and "PREVACID 30".
- PREVACID SoluTab delayed-release orally disintegrating tablets: 15 mg strength is a white to yellowish white, uncoated round tablet containing orange to dark brown speckles with "15" debossed on one side. 30 mg strength is a white to yellowish white, uncoated round tablet containing orange to dark brown speckles with "30" debossed on one side.
- Delayed-release capsules: 30 mg.
- Delayed-release orally disintegrating tablets: 15 mg and 30 mg.
Prevacid 24 HR
Lansoprazole 15 mg
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
Prevacid
- Recommended Dosage: See full prescribing information for complete dosing information for PREVACID and PREVACID SoluTab by indication and age group and dosage adjustment in patients with severe hepatic impairment.
- Administration Instructions
- PREVACID capsules Should be swallowed whole. See full prescribing information for alternative administration options. PREVACID SoluTab Should not be broken or cut. Should not be chewed. Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. See full prescribing information for alternative administration options.
Prevacid 24 HR
- • adults 18 years of age and older
- • this product is to be used once a day (every 24 hours), every day for 14 days
- • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
- • swallow 1 capsule with a glass of water before eating in the morning
- • take every day for 14 days
- • do not take more than 1 capsule a day
- • swallow whole. Do not crush or chew capsules.
- • do not use for more than 14 days unless directed by your doctor
- • you may repeat a 14-day curse every 4 months
- • do not take for more than 14 days or more often than every 4 months unless directed by a doctor
- • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
Most common adverse reactions
The adverse reactions the label reports as most common.
Prevacid
The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis Clostridium difficile -Associated Diarrhea Bone Fracture Severe Cutaneous Adverse Reactions Cutaneous and Systemic Lupus Erythematosus Cyanocobalamin (Vitamin B12) Deficiency Hypomagnesemia and Mineral Metabolism Fundic Gland Polyps Most commonly reported adverse reactions...
Prevacid 24 HR
- • your heartburn continues or worsens
- • you need to take this product for more than 14 days
- • you need to take more than 1 course of treatment every 4 months
- • you get diarrhea
- • you develop a rash or joint pain
Warnings and precautions
The warnings and precautions section of the label.
Prevacid
- Gastric Malignancy: In adults, symptomatic response with PREVACID or PREVACID SoluTab does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
- Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients.
- Clostridium difficile -Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile -associated diarrhea.
- Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
- Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
- Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PREVACID and PREVACID SoluTab and refer to specialist for evaluation.
- Cyanocobalamin (Vitamin B12)
- Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
Prevacid 24 HR
- • liver disease
- • had heartburn over 3 months. This may be a sign of a more serious condition.
- • frequent wheezing, particularly with heartburn
- • unexplained weight loss
- • nausea or vomiting
- • stomach pain
Contraindications
Situations in which the label states the medication must not be used.
Prevacid
- PREVACID and PREVACID SoluTab are contraindicated in patients with known hypersensitivity to any component of the formulation.
- Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria.
- Proton Pump Inhibitors (PPIs), including PREVACID and PREVACID SoluTab, are contraindicated with rilpivirine-containing products.
- For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Contraindications section of their prescribing information.
- Patients receiving rilpivirine-containing products.
Prevacid 24 HR
- • trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- • heartburn with lightheadedness, sweating or dizziness
- • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- • frequent chest pain
- These may be signs of a serious condition. See your doctor.
Drug interactions
Interactions the label singles out.
Prevacid
- Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PREVACID or PREVACID SoluTab and instructions for preventing or managing them.
- Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
- Clinically Relevant Interactions Affecting PREVACID or PREVACID SoluTab When Coadministered with Other Drugs CYP2C19 OR CYP3A4 Inducers Clinical Impact: Decreased exposure of lansoprazole when used concomitantly with strong inducers.
- Intervention: St John's Wort, rifampin: Avoid concomitant use with PREVACID or PREVACID SoluTab.
- Ritonavir-containing products: See prescribing information.
- CYP2C19 or CYP3A4 Inhibitors Clinical Impact: Increased exposure of lansoprazole is expected when used concomitantly with strong inhibitors.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Prevacid
Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment (see Data). In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 6.4 times the maximum recommended human dose produced reductions in the offspring in femur weight, femur length, crown-rump length and growth plate thickness (males only) on postnatal Day 21...
Prevacid 24 HR
ask a health care professional before use.
Generic or brand
Generic lansoprazole is approved in both prescription and shop form.
The FDA label database lists 19 approved generic applications for this ingredient.
What affects the cost
Lansoprazole is generic and inexpensive. The prescription and over-the-counter products are sold through different channels at different prices, and neither label mentions cost.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand | Generic |
|---|---|---|
| per tablet, capsule or pen | Brand$13.23 (range $0.564 to $13.25, 177 listings) | Generic$0.170 (range $0.105 to $2.48, 2506 listings) |
Median of 2683 listings. Effective dates 2025-07-23 to 2026-08-19, file dated 2026-08-26.
What the FDA has changed in these labels
The regulator reissues a label without notice: the old wording simply stops existing. These are the latest revisions on record for the documents this page is built from.
- 16 March 2022Prevacidfrom the archive
Warnings and precautions (6 added); Adverse reactions (reworded)
- 11 December 2020Prevacidfrom the archive
Contraindications (reworded); Warnings and precautions (4 added, 3 removed); Adverse reactions (reworded)
- 28 September 2020Prevacidfrom the archive
Warnings and precautions (3 added); Adverse reactions (37 removed)
The full record for every label on this site - 6 earlier revisions for this ingredient are in the archive.
Common questions
- Is Prevacid 24 HR the same as prescription Prevacid?
- Same active ingredient, different products. The over-the-counter capsule is 15 mg once daily for 14 days in adults. The prescription product is supplied as 30 mg capsules and as orally disintegrating tablets, for ulcers, H. pylori eradication, GERD and erosive esophagitis.
- What does the prescription label warn about that the shop one does not?
- Acute tubulointerstitial nephritis, Clostridium difficile-associated diarrhea, and an increased risk of osteoporosis-related fractures of the hip, wrist or spine with long-term or multiple daily dose therapy. The over-the-counter label instead lists symptoms that mean stopping and asking a doctor.
Other medications under heartburn
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Prevacid
Takeda Pharmaceuticals America, Inc.. Label version 45, effective 8 July 2025.
FDA prescribing information for Prevacid 24 HR
L. Perrigo Company. Label version 3, effective 24 June 2025.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.