equate lansoprazole

Manufacturer
Wal-Mart Stores Inc
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:52:11

Label at a glance#

Productequate lansoprazole
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 • take 1 tablet before eating in the morning • do not crush or chew tablets • place the tablet on tongue; tablet disintegrates, with or without water. The tablets ...

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Lansoprazole 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 a prescription drug. Acid reducers 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 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

  • take 1 tablet before eating in the morning
  • do not crush or chew tablets
  • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • take every day for 14 days
  • do not take more than 1 tablet a day
  • do not use for more than 14 days unless directed by your doctor
  • do not take this medicine with alcohol

Repeated 14-Day Course (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

Inactive ingredients

INACTIVE INGREDIENT SECTION

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST

Consumer Information

PATIENT MEDICATION INFORMATION SECTION

Treats Frequent Heartburn

Lansoprazole

Delayed Release

Orally Disintegrating Tablets 15 mg

acid reducer

• May take 1 to 4 days for full effect

Please read the entire package insert before taking

Lansoprazole Delayed Release Orally Disintegrating Tablets.

Save for future reference.

How Lansoprazole delayed release orally disintegrating tablets Treats Your Frequent Heartburn

Lansoprazole delayed release orally disintegrating tablets stops acid production at the source - the pumps that release acid into the stomach. Lansoprazole delayed release orally disintegrating tablet is taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When Taking Lansoprazole delayed release orally disintegrating tablets

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole delayed release orally disintegrating tablets in the morning before eating. Lansoprazole is 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 orally disintegrating tablets every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole delayed release orally disintegrating tablets

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 orally disintegrating tablets

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

How to Take Lansoprazole delayed release orally disintegrating tablets

14-DAY Course of Treatment

  • Take 1 tablet before eating in the morning.
  • Do not crush or chew tablets.
  • Place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • Take every day for 14 days.
  • Do not take more than 1 tablet a day.
  • Do not use for more than 14 days unless directed by your doctor.
  • Do not take this medicine with alcohol.

When to Take Lansoprazole delayed release orally disintegrating tablets 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 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 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 care professional before use.

Keep out of reach of children.

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

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 that lansoprazole effectively treats frequent heartburn

In three clinical studies, lansoprazole was shown to be significantly better than placebo in treating frequent heartburn.

How Lansoprazole delayed release orally disintegrating tablets is Sold

This medicine is available in 14 tablet, 28 tablet and 42 tablet 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 orally disintegrating tablets

Call 1-800-719-9260

weekdays 7:30 AM to 5:00 PM EST

Made in Israel

Manufactured by:

Dexcel Pharma Technologies Ltd.

10 Hakidma Street, Yokneam 2069200, Israel

:8U174 00 J3

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

equate™

Compare to Prevacid® 24 HR Active Ingredient

Treats Frequent Heartburn

Lansoprazole

Delayed Release Orally Disintegrating Tablets 15 mg

Acid Reducer

24 HOUR

May take 1 to 4 days for full effect

Melts in your mouth

Dissolves without water

Strawberry Flavor

15 mg

42 TABLETS

Three 14-day courses of treatment

Actual Size

8u1-2e-lansoprazole.jpg
8u1-2e-lansoprazole.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSN4
351261lansoprazole 15 MG Disintegrating Oral TabletSCD4
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSY4

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-373-55equate lansoprazole42 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D424
49035-373-55equate lansoprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-373EQUATE LANSOPRAZOLE (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [WAL-MART STORES INC]4Current NDC, Legacy NDC, 2 package rows20221208_89b91d5f-008c-4e9d-83e0-23b673b9c469.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-37349035-373-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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 44.

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
N208025-001LANSOPRAZOLELANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208025-001110770552036-04-21Drug product2021-08-03
N208025-001119865542036-04-21Drug product2024-05-21

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 · 44 observed states.

Captured, Edition, Application-product table
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Observed Orange Book patent history#

Patent history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
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2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208025-001119865542036-04-21Drug product2024-05-212680178bc6a6…
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2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208025-001110770552036-04-21Drug product2021-08-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208025-001119865542036-04-21Drug product2024-05-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208025-001110770552036-04-21Drug product2021-08-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208025-001119865542036-04-21Drug product2024-05-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208025-001110770552036-04-21Drug product2021-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208025-001110770552036-04-21Drug product2021-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208025-001110770552036-04-21Drug product2021-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208025-001110770552036-04-21Drug product2021-08-034b0b4de00fa7…
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2024-02-18 07:12 UTC2024-02N208025-001110770552036-04-21Drug product2021-08-031c564ffb4f44…

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
equate lansoprazoleLANSOPRAZOLEWal-Mart Stores Inc89b91d5f-008c-4e9d-83e0-23b673b9c4692022-12-07WarningsExact identifier
ndc (package): 49035-373-55
ndc (product): 49035-373
ndc11 (package): 49035037355
spl id: 541f5b17-f2fe-428c-bf83-01d59bba6a97
spl set id: 89b91d5f-008c-4e9d-83e0-23b673b9c469

Reported adverse events (FAERS/openFDA)#

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