Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID d52b26e2-3d2a-4067-a28b-8697f865f582
Route
ORAL
Published
Effective Date 2025-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lansoprazole (15 mg)
Inactive Ingredients
Ferrosoferric Oxide Silicon Dioxide Starch, Corn Fd&c Blue No. 1 Fd&c Red No. 3 Fd&c Red No. 40 Gelatin Hydroxypropyl Cellulose, Unspecified Hydroxypropyl Cellulose, Low Substituted Magnesium Carbonate Methacrylic Acid And Ethyl Acrylate Copolymer Polyethylene Glycol, Unspecified Polysorbate 80 Shellac Ammonia Sucrose Talc Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: MYL;LD15 Shape: capsule Color: pink Color: green Size: 18 mm Score: 1
Marketing Status
ANDA Completed Since 2019-03-31 Until 2026-12-31

Description

Lansoprazole USP, 15 mg

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Lansoprazole USP, 15 mg

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

Allergy alert: Do not use if you are allergic to lansoprazole.

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.
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.
Package Label
CVS HEALTH Lansoprazole 15 mg
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 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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Prevacid® 24HR*

Lansoprazole

DELAYED-RELEASE CAPSULES USP, 15 mg

Acid reducer

Treat frequent heartburn

  • May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
  • Sodium free

SAFETY-SEALED CAPSULES

One 14-day course of treatment

*This product is not manufactured or distributed by Takeda Pharmaceuticals North America, Inc., owner of the registered trademark Prevacid®, or by GSK Consumer Healthcare, distributor of the Prevacid® 24HR product.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP OR BLACK BAND AROUND THE CENTER OF EACH CAPSULES IS BROKEN OR MISSING.

KEEP OUTER CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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.

Active Ingredient (in Each Capsule)

Lansoprazole USP, 15 mg

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 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
  • 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)

Structured Label Content

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
Purpose

Acid reducer

Warnings (WARNINGS)

Allergy alert: Do not use if you are allergic to lansoprazole.

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.
Do Not Use (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.
Package Label
CVS HEALTH Lansoprazole 15 mg
Other Information (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 Ingredients (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

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Prevacid® 24HR*

Lansoprazole

DELAYED-RELEASE CAPSULES USP, 15 mg

Acid reducer

Treat frequent heartburn

  • May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
  • Sodium free

SAFETY-SEALED CAPSULES

One 14-day course of treatment

*This product is not manufactured or distributed by Takeda Pharmaceuticals North America, Inc., owner of the registered trademark Prevacid®, or by GSK Consumer Healthcare, distributor of the Prevacid® 24HR product.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP OR BLACK BAND AROUND THE CENTER OF EACH CAPSULES IS BROKEN OR MISSING.

KEEP OUTER CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Lansoprazole USP, 15 mg

Ask A Doctor Before Use If You Have (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 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
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
Ask A Doctor Or Pharmacist Before Use If You Are (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)

Advanced Ingredient Data


Raw Label Data

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