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Prevacid 24 HR

Package insert / prescribing information
Generic name: lansoprazole
Dosage form: capsule, coated, extended release
Drug class: Proton pump inhibitors

Medically reviewed by Drugs.com. Last updated on Jun 1, 2021.

Active ingredient (in each capsule)

Lansoprazole 15 mg

Purpose

Acid Reducer

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

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 a prescription drug. Acid reducers may interact with certain prescription drugs.

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.

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 information

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

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?

1-855-328-5199

Principal Display Panel

NDC 0067-6286-42

Treats Frequent Heartburn

PREVACID 24HR

Lansoprazole delayed-release capsules 15 mg / acid reducer

May take 1 to 4 days for full effect
Sodium Free

42 CAPSULES

THREE 14-DAY COURSES OF TREATMENT

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2019 GSK group of companies or its licensor.

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

TAMPER-EVIDENT BOTTLE. DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” OR BLACK BAND AROUND THE CENTER OF EACH CAPSULE IS MISSING OR BROKEN.

62000000031308

PREVACID 24 HR
lansoprazole capsule, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-6286
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE 15 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 40
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM CARBONATE
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (Teal) , PINK Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code P24HR
Contains
Packaging
# Item Code Package Description
1 NDC:0067-6286-14 1 BOTTLE in 1 CARTON
1 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
2 NDC:0067-6286-28 2 BOTTLE in 1 PACKAGE, COMBINATION
2 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
3 NDC:0067-6286-42 3 BOTTLE in 1 PACKAGE, COMBINATION
3 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
4 NDC:0067-6286-29 3 BOTTLE in 1 PACKAGE, COMBINATION
4 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022327 10/12/2009 08/31/2022
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC