FDA.reportPublic FDA data

Lansoprazole Delayed Release Capsules USP

Manufacturer
Gericare Pharmaceuticals
Effective date
2024-12-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:48:06

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 days swallow whole. Do not crush or che...

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Lansoprazole  USP, 15 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use(s)

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 taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • warfarin (blood-thinning medicine)
  • prescription antifungal or anti-yeast medicines
  • digoxin (heart medicine)
  • theophylline (asthma medicine)
  • tacrolimus (immune system medicine)
  • atazanavir (medicine for HIV infection)

Stop use and ask 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

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

  • 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 days
  • 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 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

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

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Principal Display Panel - container carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container carton : 14's count

cartoncarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-761LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]4Legacy NDC20241203_62dce6af-b33d-fa49-7861-670565fdf6e1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LansoprazoleACTIVE INGREDIENT0K5C5T2QPG1
LansoprazoleACTIVE MOIETY0K5C5T2QPG1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GELATININACTIVE INGREDIENT2G86QN327L1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671P1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K141
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NA1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8J1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WE1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
SUCROSEINACTIVE INGREDIENTC151H8M5541
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

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
57896-76157896-761-42
55111-739

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lansoprazole0K5C5T2QPGACTIB
FD&C BLUE NO. 2L06K8R7DQKIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
GELATIN2G86QN327LIACT
HYDROXYPROPYL CELLULOSERFW2ET671PIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED2165RE0K14IACT
MAGNESIUM CARBONATE0E53J927NAIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 19 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14TABLET, DELAYED RELEASE / ORAL103 mgExact identifier — unii+route
4 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE / ORAL46 mgExact identifier — unii+route+dosage form
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
POLYETHYLENE GLYCOL 6000POLYETHYLENE GLYCOL 600030IQX730WECAPSULE, DELAYED RELEASE / ORAL35 mgExact identifier — unii+route+dosage form
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii+route+dosage form
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14TABLET / ORAL480 mgExact identifier — unii+route
4 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii+route+dosage form
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14CAPSULE / ORAL150 mgExact identifier — unii+route
4 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii+route+dosage form
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AMETHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JCAPSULE, DELAYED RELEASE / ORAL1321 mgExact identifier — unii+route+dosage form
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii+route+dosage form
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route+dosage form
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14TABLET, FILM COATED / ORAL40 mgExact identifier — unii+route
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route+dosage form
MAGNESIUM CARBONATEMAGNESIUM CARBONATE0E53J927NACAPSULE, DELAYED RELEASE / ORAL180 mgExact identifier — unii+route+dosage form
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, DELAYED RELEASE / ORAL150 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE, DELAYED RELEASE / ORAL0.22 mgExact identifier — unii+route+dosage form
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii+route+dosage form

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
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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18c2088c7a36db…
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…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Limited15e05eda-48aa-a4b7-4b8a-4ee1cf1101202026-07-09WarningsExact identifier
ndc (product): 55111-739
0a0a6fed-e461-7bbe-ae4a-178f37bfb3dd62dce6af-b33d-fa49-7861-670565fdf6e12025-07-18WarningsExact identifier
spl set id: 62dce6af-b33d-fa49-7861-670565fdf6e1

Reported adverse events (FAERS/openFDA)#

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