PREVACID 24 HR- lansoprazole capsule, delayed release 
L. Perrigo Company

----------

Prevacid 24HR Drug Facts

Active ingredient (in each capsule)

Lansoprazole 15 mg

Purpose

Acid Reducer

Use

treats frequent heartburn (occurs 2 or moredays 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, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, starch, sucrose, sugar sphere, talc, titanium dioxide

Questions or comments?

1-800-864-9649

Consumer Information

Treats Frequent Heartburn

PERRIGO Selfcare

24HR

PREVACID®

Lansoprazole delayed-release capsules 15 mg/acid reducer

May take 1 to 4 days for full effect
Sodium Free

Please read the entire package insert before taking PREVACID®24HR.

Save for future reference.

How PREVACID®24HR Treats Your Frequent Heartburn

PREVACID®24HR stops acid production at the source – the pumps that release acid into the stomach. PREVACID®24HR is taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When Taking PREVACID®24HR

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take PREVACID®24HR in the morning before eating. PREVACID®24HR is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take PREVACID®24HR every day for 14 days to treat your frequent heartburn.

Who Should Take PREVACID®24HR

Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.

Who Should NOT Take PREVACID®24HR

People who have one episode of heartburn a week or less, or who want immediate relief of heartburn.

How to Take PREVACID®24HR

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.

When to Take PREVACID®24HR Again

You may repeat a 14-day course of therapy every 4 months.

When to Talk to Your Doctor

Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

Warnings and When to Ask Your Doctor

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.

Tips for Managing Heartburn

Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
Eat slowly and do not eat big meals.
Do not eat late at night or just before bedtime.
Do not lie flat or bend over soon after eating.
Raise the head of your bed.
Wear loose-fitting clothing around your stomach.
If you are overweight, lose weight.
If you smoke, quit smoking.

Clinical studies prove PREVACID®24HR effectively treats frequent heartburn

In three clinical studies, PREVACID®24HR was shown to be significantly better than placebo in treating frequent heartburn.

How PREVACID®24HR is Sold

PREVACID®24HR is available in 14 capsule and 42 capsule sizes. These sizes contain one and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For Questions or Comments About PREVACID®24HR

Call 1-800-864-9649

Distributed By

Perrigo®

Allegan, MI 49010

perrigo.com

PREVACID® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc., used under license by Perrigo Pharma International - DAC.

54H00 PB J1

62000000045765

Package/Label Principal Display Panel

Treats Frequent Heartburn

PERRIGO Selfcare

24HR

PREVACID

Lansoprazole delayed-release capsules 15 mg / acid reducer

May take 1 to 4 days for full effect

Sodium Free

14 CAPSULES

ONE 14-DAY COURSE OF TREATMENT

Prevacid 24HR Carton Image 1
Prevacid 24HR Carton Image 2
PREVACID 24 HR 
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-6002
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:0113-6002-011 in 1 CARTON12/05/201912/05/2019
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0113-6002-033 in 1 CARTON12/04/201912/04/2019
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02232712/04/201912/05/2019
Labeler - L. Perrigo Company (006013346)

Revised: 1/2020
 
L. Perrigo Company