Lansoprazole

Manufacturer
Reliable 1 Laboratories
Effective date
2019-09-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:08:35

Label at a glance#

ProductLansoprazole
Active ingredientLANSOPRAZOLE
Label structure14 sections

Indications and uses

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

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 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 c...

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Lansoprazole USP, 15 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

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

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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

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 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 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

OTHER SAFETY 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 INGREDIENT SECTION

FD&C Blue No.2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-375-3784

OTC - ASK DOCTOR SECTION

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 wheesing, particulary with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-055-42

Compare to the active ingredient in Prevacid 24HR Capsules

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Reliable-1 Laboratories

Lansoprazole

Delayed-Release Capsules, USP 15 mg

Acid Reducer

24 HR

42 Capsules

Three 14-Day Cources of Treatment

CartonCarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-055-422021-08-09C16284748780-1c7ccaba7-2808-fd44-e053-dadaa90aa01bLansoprazole15mg
69618-055-422021-07-23C16284748780-1c7ccaba7-2808-fd44-e053-dadaa90aa01bLansoprazole15mg

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-05569618-055-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
A202194-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18

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 22:38:342026-08A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1884e616aacf4f…
2026-08-18 06:07:402026-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183f01610625f2…
2019-09-15 20:21 UTC2019-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18f41ea6bd6efb…

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
c927b93b-724e-41ec-e053-2a95a90a9180907bcf2d-0cbf-1d67-e053-2995a90a39d22021-08-09WarningsExact identifier
spl set id: 907bcf2d-0cbf-1d67-e053-2995a90a39d2

Reported adverse events (FAERS/openFDA)#

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