Lansoprazole

Manufacturer
Chain Drug Consortium, LLC
Effective date
2022-10-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:51:32

Label at a glance#

ProductLansoprazole
Active ingredientLANSOPRAZOLE
Label structure10 sections

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Lansoprazole USP, 15 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT IN PREVACID® 24HR

Heartburn Relief 24 Hour™

Lansoprazole Delayed-Release Capsules USP, 15 mg

ACID REDUCER

  • Treats frequent heartburn
  • May take 1 to 4 days for full effect
  • Sodium free

CAPSULES

THREE 14-DAY COURSES 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: Pharmacy Value Alliance, LLC

407 East Lancaster Avenue, Wayne, PA 19087

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREMIER VALUE Heartburn Relief 24 Hour
PREMIER VALUE Heartburn Relief 24 Hour

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-75868016-758-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203187-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-0184e616aacf4f…
2026-08-18 06:07:402026-07A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-013f01610625f2…
2019-09-15 20:21 UTC2019-09A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
700fa545-34be-4de4-bf6a-dfad3a0465ef54522c2c-ea18-442c-8694-4e8110fa009d2025-02-28WarningsExact identifier
spl set id: 54522c2c-ea18-442c-8694-4e8110fa009d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.