Prevacid

Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2017-07-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:14:37

Label at a glance#

ProductPrevacid 24 HR

Active ingredientLANSOPRAZOLE

Label structure9 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 chew...

Contacts and useful links#

PhoneLabel contact1-800-452-0051

Label contents#

Full prescribing information#

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

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.
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 lose
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 medication)

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

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.

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 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

colloidal silicon dioxide, D&C red No. 28, FD&C blue No. 1, FD&C Green No. 3, FD&C red No. 40, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacryclic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, starch, sucrose, sugar sphere, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-452-0051

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1883-1	2020-07-20	C162847	48780-1	9d75b9d0-8c05-f424-e053-dadaa90a57ce	Drug Facts
68071-1883-1	2020-01-31	C162847	48780-1	9d75b9d0-8c05-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-6286-14	EA - Each	0067-6286	05f22d41-73b0-4c5e-877b-02b6f3be53bd	1	2012-07-24
0067-6286-28	EA - Each	0067-6286	20086176-4cda-4d36-9049-fa0f1104a864	1	2012-07-24
0067-6286-42	EA - Each	0067-6286	43b7f158-53a6-437e-9697-562cd0256a7d	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Prevacid 24 HR
Lansoprazole
SILICON DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 40
GELATIN
HYDROXYPROPYL CELLULOSE (TYPE H)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM CARBONATE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
POLYETHYLENE GLYCOLS
POLYSORBATE 80
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-1883	68071-1883-1
0067-6286

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
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
HYDROXYPROPYL CELLULOSE (TYPE H)	RFW2ET671P	IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	2165RE0K14	IACT
MAGNESIUM CARBONATE	0E53J927NA	IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
STARCH, CORN	O8232NY3SJ	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
LANSOPRAZOLE	0K5C5T2QPG	ACTIB

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022327-001	PREVACID 24 HR	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD, RS	2009-05-18

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a36f4fc3-9c24-c197-e053-2995a90a7285			552c58cd-5b91-34bf-e054-00144ff88e88	2020-04-16	Warnings	Exact identifier spl set id: 552c58cd-5b91-34bf-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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