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Prevacid 24 HR

Pronunciation

Generic Name: lansoprazole
Dosage Form: capsule, coated, extended release

Prevacid 24 HR
Lansoprazole delayed-release capsules 15mg / acid reducer

Active ingredient

Lansoprazole 15mg 

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Purpose

Acid reducer

Uses

  • 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 Doctor

  • warfarin (blood-thinning medicine) 
  •  prescription antifungal or anti-yeast medicines 
  •  digoxin (heart medicine) 
  •  theophylline (asthma medicine) 
  •  tacrolimus (immune system medicine) 
  •  atazanavir (medicine for HIV infection)

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

If pregnant or breast feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

In case of overdose

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 20-250   C (68-77   F)
  • keep product out of high heat and humidity 
  • protect product from moisture

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 copolymer, polyethylene glycol, polysorbate 80, starch, sucrose, sugar sphere, talc, titanium dioxide

Questions or Comments?

Questions or comments? 1-800-452-0051

Distributed by: Novartis Consumer Health, Inc.,

Parsippany, NJ 07054-0622 ©2009 U.S. Patent No. 4,628,098

PREVACID® is a registered trademark of Takeda Pharmaceuticals North America, Inc.

Principal Display Panel

PREVACID  24 HR
lansoprazole capsule, coated, extended 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
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  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED  
MAGNESIUM CARBONATE  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
POLYETHYLENE GLYCOL  
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 14 CAPSULE, COATED, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE
2 NDC:0067-6286-28 2 BOTTLE (BOTTLE) in 1 PACKAGE, COMBINATION
2 14 CAPSULE, COATED, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE
3 NDC:0067-6286-42 3 BOTTLE (BOTTLE) in 1 PACKAGE, COMBINATION
3 14 CAPSULE, COATED, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE
4 NDC:0067-6286-98 60000 CAPSULE, COATED, EXTENDED RELEASE (CAPSULE) in 1 DRUM
5 NDC:0067-6286-99 49500 CAPSULE, COATED, EXTENDED RELEASE (CAPSULE) in 1 DRUM
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022327 11/12/2009
Labeler - Novartis Consumer Health, Inc. (879821635)
Revised: 08/2009
 
Novartis Consumer Health, Inc.



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