PREVACID 24 HR- lansoprazole capsule, delayed release 
NuCare Pharmaceuticals,Inc.

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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.
  • 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 lose
  • nausea or vomiting
  • stomach pain

Ask a doctor or pharmacist before use if you are taking

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

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

If pregnant or breast-feeding,

ask a health 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?

1-800-452-0051

Principal Display Panel

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PREVACID  24 HR
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-1883(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 (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
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:68071-1883-114 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02232710/12/200912/31/2018
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-1883)

Revised: 4/2020
 
NuCare Pharmaceuticals,Inc.