LANSOPRAZOLE- lansoprazole capsule, delayed release 
Safeway, Inc.

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Drug Facts

Active ingredient (in each capsule)

Lansoprazole 15 mg

Purpose

Acid reducer

Use

WARNINGS

Clostridium difficile-associated diarrhea (CDAD): A diagnosis of CDAD should be considered for patients taking Proton Pump Inhibitors (PPIs) who develop diarrhea that does not improve. Symptoms include:

Patients should seek immediate care from a healthcare professional if these symptoms do not go away while taking this medication.

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 (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,

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

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

colloidal silicon dioxide, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide

Questions or comments?

Call 1-888-SAFEWAY

Monday-Friday 7AM-6PM PST

Principal Display Panel

Compare to Active Ingredient in Prevacid®24HR*

24 Hour

Lansoprazole

Delayed-Release Capsules, USP 15 mg

Acid Reducer

Sodium Free

SEE NEW WARNINGS INFORMATION

CAPSULES  14-DAY COURSE OF TREATMENT

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

TAMPER-EVIDENT BOTTLE

Do not use if inner foil seal imprinted with "Sealed For Your Protection" or dark blue to black gelatin band around the center of each capsule is missing or broken.

DISTRIBUTED BY SAFEWAY INC.

P.O. BOX 99, PLEASANTON, CA  94566-0009

1-888-SAFEWAY / www.safeway.com

Product of India

*This product is not manufactured or distributed by Takeda Pharmaceuticals North America, Inc., owner of the registered trademark Prevacid®, or by Novartis Consumer Health, Inc., distributor of the Prevacid®24HR product.

Product label

 Lansoprazole USP 15 mg

Safeway Lansoprazole Capsule

LANSOPRAZOLE 
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-019(NDC:64679-140)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINK, GREENScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code W140
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-019-141 in 1 BOX
114 in 1 BOTTLE
2NDC:21130-019-423 in 1 BOX
214 in 1 BOTTLE
3NDC:21130-019-282 in 1 BOX
314 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20272712/31/2012
Labeler - Safeway, Inc. (009137209)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 1/2013
Document Id: ef523ae9-f41b-4faf-8a6f-6cd4538e6be1
Set id: 5cd41b0a-190d-4460-a536-aa401dc0abb4
Version: 2
Effective Time: 20130103
 
Safeway, Inc.