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Lansoprazole by Actavis Pharma, Inc.

Dosage form: capsule, delayed release
Ingredients: LANSOPRAZOLE 15mg
Labeler: Actavis Pharma, Inc.
NDC Code: 0591-2448

Lansoprazole Delayed-Release Capsules USP

Drug Facts

Active ingredient (in each capsule)

Lansoprazole USP, 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
  • 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 at 1-800-222-1222.

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° to 25°C (68° to 77°F)
•  keep product out of high heat and humidity 
•  protect product from moisture
  close cap tightly after use

Inactive ingredients

acetone, D&C Red #28, D&C Yellow #10, FD&C Blue #1, gelatin, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer type C, polyethylene glycol 4000, polysorbate 80, sugar spheres (which contain sucrose and starch), talc, titanium dioxide. Printing Ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution, titanium dioxide

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Principal Display Panel

NDC 0591-2448-14
Compare to the active ingredient in Prevacid 24® HR*

Treats Frequent Heartburn

Lansoprazole
Delayed-Release Capsules USP, 15 mg
Acid Reducer
24 Hour

May take 1 to 4 days for full effect
Sodium Free

Does not contain an ingredient derived from wheat, barley or rye

One 14-Day Course of Treatment
14 capsules

14 ct

LANSOPRAZOLE 
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0591-2448
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
ACETONE 
D&C RED NO. 28 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN, UNSPECIFIED 
HYPROMELLOSE 2910 (5 MPA.S) 
ISOPROPYL ALCOHOL 
MAGNESIUM CARBONATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
POLYETHYLENE GLYCOL 4000 
POLYSORBATE 80 
SUCROSE 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
BUTYL ALCOHOL 
ALCOHOL 
POTASSIUM HYDROXIDE 
PROPYLENE GLYCOL 
WATER 
SHELLAC 
AMMONIA 
Product Characteristics
ColorGREEN, PINKScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeL24HR
Contains    
Packaging
#Item CodePackage Description
1NDC:0591-2448-141 BOTTLE in 1 CARTON
114 CAPSULE, DELAYED RELEASE in 1 BOTTLE
2NDC:0591-2448-962 BOTTLE in 1 CARTON
214 CAPSULE, DELAYED RELEASE in 1 BOTTLE
3NDC:0591-2448-483 BOTTLE in 1 CARTON
314 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20330601/13/2016
Labeler - Actavis Pharma, Inc. (119723554)

 
Actavis Pharma, Inc.

← See all Lansoprazole brands

Medically reviewed on Nov 30, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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