BJWC Lansoprazole Drug Facts

Manufacturer
BJWC
Effective date
2026-05-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:58:32

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each capsule)

Lansoprazole 15 mg

Purpose

Acid Reducer

Uses

Use

• 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

Allergy alert: • do not use if you are allergic to lansoprazole • lansoprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away.

Directions And Dosage

Directions

• 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 Label Information

Other information

• read the directions and warnings before use • keep the package. It contains 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

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO PREVACID® 24 HR ACTIVE INGREDIENT 3 PACK berkley jensen® LANSOPRAZOLE DELAYED-RELEASE CAPSULES, 15 mg 24 HOUR ACID REDUCER TREATS FREQUENT HEARTBURN MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT • SODIUM FREE ACTUAL SIZE 42 CAPSULES THREE 14-DAY COURSES OF TREATMENT

Label Images#

berkleyjensen-lansoprazole-stretch-card-image
berkleyjensen-lansoprazole-stretch-card-image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN2
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-823-00BERKLEY AND JENSEN LANSOPRAZOLE14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
68391-823-03BERKLEY AND JENSEN LANSOPRAZOLE3 in 1 PACKAGECAPSULE, DELAYED RELEASE32

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68391-82368391-823-00, 68391-823-03

Ingredients#

Complete SPL Sections#

Active ingredient (in each capsule)

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 • lansoprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help 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 and warnings before use • keep the package. It contains 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

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO PREVACID® 24 HR ACTIVE INGREDIENT 3 PACK berkley jensen® LANSOPRAZOLE DELAYED-RELEASE CAPSULES, 15 mg 24 HOUR ACID REDUCER TREATS FREQUENT HEARTBURN MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT • SODIUM FREE ACTUAL SIZE 42 CAPSULES THREE 14-DAY COURSES OF TREATMENT

Source Document#

Source XML