Lansoprazole is an over-the-counter medicine (Proton Pump Inhibitor). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Drug class
- Proton Pump Inhibitor
- Taken
- Oral
- Label
- Amazon.com Services LLC, revised August 12, 2026 · full label on DailyMed
Purpose
Acid Reducer
What it is used for
- 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
Active ingredient
Lansoprazole 15 mg
Do not use
if you have:
- 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.
Ask a doctor before use if you have
- 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
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if
- 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
Allergy alert:
- do not use if you are allergic to lansoprazole.
- lansoprazole 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. Do not use if you have:
- 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. Ask a doctor before use if you have
- 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 Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if
- 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 If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children
. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Lansoprazole in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdi…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
- Lots / codes
- Lot#: 411988, Exp date: 05/31/2025
- Distribution
- Nationwide in the US
- Quantity
- 30 bottles
- Recall started
- March 27, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0438-2024
-
Class II Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Reason: CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Lots, distribution and details
- Lots / codes
- Lot # 411987 Exp: 05/2025
- Distribution
- Nationwide in the USA
- Quantity
- 4260 bottles
- Recall started
- February 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0318-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Lansoprazole
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID d0a7e6e0-9a76-4a5a-aed7-aa976a174c0e.