LANSOPRAZOLE- lansoprazole capsule, delayed release 
Walgreen Co

----------

Lansoprazole Delayed Release Capsules USP

Active ingredient(s)

Lansoprazole  USP, 15 mg

Purpose

Acid reducer

Use(s)

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 (immune system medicine)
  • atazanavir (medicine for HIV infection)

Stop use and ask 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. (1-800-222-1222)

Directions

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

FD&C Blue No. 2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide

Questions or comments?

call 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Principal Display Panel

Container : 14's count

container

Principal Display Panel

Container carton : 14's count

carton

LANSOPRAZOLE 
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0739
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lansoprazole (UNII: 0K5C5T2QPG) (Lansoprazole - UNII:0K5C5T2QPG) Lansoprazole15 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (opaque pink colored cap) , GREEN (opaque green colored body) Scoreno score
ShapeCAPSULESize3mm
FlavorImprint Code RDY;398
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0739-272 in 1 PACKAGE, COMBINATION05/18/2012
1NDC:0363-0739-5214 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0363-0739-333 in 1 PACKAGE, COMBINATION05/18/2012
2NDC:0363-0739-5214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20219405/18/2012
Labeler - Walgreen Co (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Reddy's Laboratories Limited (FTO III)918608162analysis(0363-0739) , manufacture(0363-0739)

Revised: 12/2019
Document Id: 19c5c0c9-0ead-96f2-827f-cc44daeb2c77
Set id: f6c3bbad-1739-80de-feb3-f9d1d1e39544
Version: 2
Effective Time: 20191210
 
Walgreen Co