Lansoprazole DR Capsules USP 15 mg

Manufacturer
Sam's West, Inc.
Effective date
2018-09-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:02:05

Label at a glance#

ProductLansoprazole
Active ingredientLANSOPRAZOLE
Label structure11 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 che...

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:

SPL UNCLASSIFIED SECTION

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 taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • warfarin (blood-thinning medicine)
  • prescription antifungal or anti-yeast medicines
  • digoxin (heart medicine)
  • theophylline (asthma medicine)
  • tacrolimus or mycophenolate mofetil (immune system medicines)
  • atazanavir (medicine for HIV infection)
  • methotrexate (arthritis medicine)
  • presently taking a prescription drug.  Antacids may interact with certain prescription drugs.

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

SPL UNCLASSIFIED SECTION

  • read the directions, warnings and package insert before use
  • keep the package and package insert.  They contain important information.
  • store at 20-25ºC (68-77ºF).
  • 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 No. 1, FD&C Red No. 3, FD&C Red No. 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

1-877-446-3679 (1-877-4-INFO-RX).

Consumer Information

SPL UNCLASSIFIED SECTION

Treats Frequent Heartburn  

LANSOPRAZOLE DELAYED-RELEASE CAPSULES, USP

(lan soe′ pra zole)

15 mg

                      Acid Reducer

• May take 1 to 4 days for full effect

• Sodium Free

Please read the entire package insert before taking lansoprazole delayed-release capsules.

Save for future reference.

How Lansoprazole Delayed-Release Capsules Treat Your Frequent Heartburn

Lansoprazole delayed-release capsules stop acid production at the source – the pumps that release acid into the stomach. Lansoprazole delayed-release capsules are taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When Taking Lansoprazole Delayed-Release Capsules

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take lansoprazole delayed-release capsules in the morning before eating. Lansoprazole delayed-release capsules are clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take lansoprazole delayed-release capsules every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole Delayed-Release Capsules

Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.

Who Should NOT Take Lansoprazole Delayed-Release Capsules

People who have one episode of heartburn a week or less, or who want immediate relief of heartburn.

How to Take Lansoprazole Delayed-Release Capsules 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.

When to Take Lansoprazole Delayed-Release Capsules Again

You may repeat a 14-day course of therapy every 4 months.

When to Talk to Your Doctor

Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

Warnings and When to Ask Your Doctor

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 your 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 medicines)

• 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.

Tips for Managing Heartburn

• Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.

• Eat slowly and do not eat big meals.

• Do not eat late at night or just before bedtime.

• Do not lie flat or bend over soon after eating.

• Raise the head of your bed.

• Wear loose-fitting clothing around your stomach.

• If you are overweight, lose weight.

• If you smoke, quit smoking.

Clinical studies prove lansoprazole delayed-release capsules effectively treat frequent heartburn

In three clinical studies, lansoprazole delayed-release capsules were shown to be significantly better than placebo in treating frequent heartburn.

How Lansoprazole Delayed-Release Capsules are Sold

Lansoprazole delayed-release capsules are available in 14 capsule, 28 capsule and 42 capsule sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For Questions or Comments About Lansoprazole Delayed-Release Capsules

Call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

 

Revised: 4/2018

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Prevacid® 24HR active ingredient*

NDC 68196-030-03

Member's MarkTM

24 hour

Lansoprazole Delayed-Release Capsules, USP 15 mg

Acid Reducer

  • May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
  • Clinically proven to treat frequent heartburn
  • Sodium Free

Value 3 Pack

actual size

42 Capsules

Three 14-day courses of treatment

KEEP THE PACKAGE AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

TAMPER-EVIDENT BOTTLE. DO NOT USE IF TAMPER-EVIDENT INNER OR BLACK BAND AROUND THE CENTER OF EACH CAPSULE IS MISSING OR BROKEN.

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Prevacid® 24HR.

LABORATORY TESTED - QUALITY ASSURED

GLUTEN FREE

100% MONEY BACK GUARANTEE

QUALITY AND PERFORMANCE

We would like to hear from you with any comments or suggestions.

In the continental U.S. or Canada, you can call us at 1-877-446-3679 (1-877-4-INFO-RX)

from 7:30 a.m. to 5 p.m. ET Monday - Friday.

DISTRIBUTED BY:

SAM'S WEST, INC.

BENTONVILLE, AR 72716

 DP23446 Lansoprazole DR Capsules USP 15 mgDP23446 Lansoprazole DR Capsules USP 15 mg

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lansoprazole Insert DP23064
Lansoprazole Insert DP23064

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN5
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LANSOPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-030-032024-01-30C16284748780-11030e365-5b85-111a-e063-dadaa90a10e2Lansoprazole DR Capsules USP 15 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-030-01Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
68196-030-03Lansoprazole3 in 1 PACKAGECAPSULE, DELAYED RELEASE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-030LANSOPRAZOLE (LANSOPRAZOLE DELAYED RELEASE) CAPSULE, DELAYED RELEASE [SAM'S WEST, INC.]5Legacy NDC, 2 package rows20191219_2732e2b8-2ba0-40f3-9ca1-d6552c18455f.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68196-03068196-030-01, 68196-030-03

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
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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…
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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…
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2023-12-20 04:57 UTC2023-12A203187-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2016-06-01ea1830bbd6c7…
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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…
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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
b20bf1de-1e61-404b-beed-87b7367fc6832732e2b8-2ba0-40f3-9ca1-d6552c18455f2018-09-24WarningsExact identifier
spl id: b20bf1de-1e61-404b-beed-87b7367fc683
spl set id: 2732e2b8-2ba0-40f3-9ca1-d6552c18455f

Reported adverse events (FAERS/openFDA)#

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