Your browser does not support JavaScript! LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]
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RxNorm Names

LANSOPRAZOLE capsule, delayed release
[Wockhardt Limited]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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.
  • 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

  • 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

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 1-800-346-6854

Poison Control Center:

Call 1-800-222-1222

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.130212

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle Label
Bottle Carton
Bottle Carton
Bottle Carton
Bottle Label
LANSOPRAZOLE 
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55648-140
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYPROMELLOSES 
MAGNESIUM CARBONATE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
SILICON DIOXIDE 
STARCH, CORN 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
Product Characteristics
ColorPINK (Opaque dark pink cap) , GREEN (Opaque dark green body) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code W;140
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-140-004500 in 1 POUCH
2NDC:55648-140-011 in 1 CARTON
214 in 1 BOTTLE
3NDC:55648-140-082 in 1 CARTON
314 in 1 BOTTLE
4NDC:55648-140-093 in 1 CARTON
414 in 1 BOTTLE
5NDC:55648-140-071 in 1 CARTON
514 in 1 BLISTER PACK
6NDC:55648-140-102 in 1 CARTON
614 in 1 BLISTER PACK
7NDC:55648-140-113 in 1 CARTON
714 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20272705/18/2012
Labeler - Wockhardt Limited (650069115)
Registrant - Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited916489953Manufacture

Revised: 5/2012
 
Wockhardt Limited

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