Lansoprazole
DRUG FACTS
d52b26e2-3d2a-4067-a28b-8697f865f582
HUMAN OTC DRUG LABEL
Aug 20, 2025
CVS Pharmacy
DUNS: 062312574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (20)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Label

CVS HEALTH Lansoprazole 15 mg
INDICATIONS & USAGE SECTION
Use
- treats frequent heartburn (occurs2 or moredays a week)
- not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each capsule)
Lansoprazole USP, 15 mg
OTC - PURPOSE SECTION
Purpose
Acid reducer
WARNINGS SECTION
WARNINGS
**Allergy alert:**Do not use if you are allergic to lansoprazole.
Do not use
- if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. 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.
- heartburn withlightheadedness, sweating or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequentchest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
Ask a doctor or pharmacist before use if you are
taking
- warfarin (blood-thinning medicine)
- prescription antifungal or anti-yeast medicines
- digoxin (heart medicine)
- theophylline (asthma medicine)
- tacrolimus or mycophenolate mofetil (immune system medicine)
- atazanavir (medicine for HIV infection)
- methotrexate (arthritis medicine)
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 professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- 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
14-Day Course of Treatment
- 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
Repeated 14-Day Courses (if needed)
- you may repeat a 14-day course 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.
STORAGE AND HANDLING SECTION
Other information
- read the directions, warnings and package insert before use
- keep the carton and package insert. They contain important information.
- store at 20°-25°C (68°-77°F)
- keep product out of high heat and humidity
- protect product from moisture
- close cap tightly after use
INACTIVE INGREDIENT SECTION
Inactive ingredients
black iron oxide,colloidal silicon dioxide, corn starch, FD&C Blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide, yellow iron oxide
OTC - QUESTIONS SECTION
Questions or comments?
Call** 1-877-753-3935**Monday-Friday 9AM-5PM EST