MedPath

Lansoprazole

DRUG FACTS

Approved
Approval ID

d52b26e2-3d2a-4067-a28b-8697f865f582

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

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
NDC Product Code69842-755
Application NumberANDA203187
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (20)

LANSOPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

Package Label

![Lansoprazole USP, 15 mg](/dailymed/image.cfm?name=lansoprazole-15-mg- capsules-delisted-1.jpg&id=894103)

CVS HEALTH Lansoprazole 15 mg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

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

LOINC: 55106-9Updated: 8/20/2025

Active ingredient (in each capsule)

Lansoprazole USP, 15 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2025

Purpose

Acid reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

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

LOINC: 34068-7Updated: 8/20/2025

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

LOINC: 44425-7Updated: 8/20/2025

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

LOINC: 51727-6Updated: 8/20/2025

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

LOINC: 53413-1Updated: 8/20/2025

Questions or comments?

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.