Prevacid 24 HR

Generic Name: lansoprazole

Dosage Form: capsule, coated, extended release
Prevacid 24 HR

Lansoprazole delayed-release capsules 15mg / acid reducer

Active ingredient

Lansoprazole 15mg 

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 0   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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 0067-6286-14 14 CAPSULE In 1 BOTTLE None 2 0067-6286-28 2 BOTTLE In 1 PACKAGE, COMBINATION contains a BOTTLE 2 14 CAPSULE In 1 BOTTLE This package is contained within the PACKAGE, COMBINATION (0067-6286-28) 3 0067-6286-42 3 BOTTLE In 1 PACKAGE, COMBINATION contains a BOTTLE 3 14 CAPSULE In 1 BOTTLE This package is contained within the PACKAGE, COMBINATION (0067-6286-42) 4 0067-6286-98 60000 CAPSULE In 1 DRUM None 5 0067-6286-99 49500 CAPSULE In 1 DRUM None

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: 08/2009Novartis Consumer Health, Inc.

More Prevacid 24 HR resources

• Prevacid 24 HR Side Effects (in more detail)
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• Drug Images
• Prevacid 24 HR Drug Interactions
• Prevacid 24 HR Support Group
• 27 Reviews for Prevacid 24 HR - Add your own review/rating

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