PREVACID 24 HR- lansoprazole capsule, delayed release 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

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

62000000031308_Prevacid 24HR_Capsules_42CT.JPG
PREVACID  24 HR
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6286
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (Teal) , PINKScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code P24HR
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6286-141 in 1 CARTON10/12/200908/31/2022
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-6286-282 in 1 PACKAGE, COMBINATION10/12/200908/31/2022
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0067-6286-423 in 1 PACKAGE, COMBINATION10/12/200908/31/2022
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0067-6286-293 in 1 PACKAGE, COMBINATION10/12/200905/03/2019
414 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02232710/12/200908/31/2022
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 6/2021
Document Id: 7f6cc3d5-6355-48cb-b50a-958b1e96aa90
Set id: fd4629d5-b876-4ae9-bb32-c3560ad416a9
Version: 11
Effective Time: 20210616
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC