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Lansoprazole by Wockhardt Limited

Medically reviewed on May 10, 2018

Dosage form: capsule, delayed release
Ingredients: LANSOPRAZOLE 15mg
Labeler: Wockhardt Limited
NDC Code: 55648-140

Lansoprazole Delayed-Release Capsules USP, 15 mg

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
LANSOPRAZOLE 
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem 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 CodeW;140
Contains    
Packaging
#Item CodePackage Description
1NDC:55648-140-004500 CAPSULE, DELAYED RELEASE (4500 CAPSULE) in 1 POUCH
2NDC:55648-140-011 BOTTLE (1 BOTTLE) in 1 CARTON
214 CAPSULE, DELAYED RELEASE (14 CAPSULE) in 1 BOTTLE
3NDC:55648-140-082 BOTTLE (2 BOTTLE) in 1 CARTON
314 CAPSULE, DELAYED RELEASE (14 CAPSULE) in 1 BOTTLE
4NDC:55648-140-093 BOTTLE (3 BOTTLE) in 1 CARTON
414 CAPSULE, DELAYED RELEASE (14 CAPSULE) in 1 BOTTLE
5NDC:55648-140-071 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
514 CAPSULE, DELAYED RELEASE (14 CAPSULE) in 1 BLISTER PACK
6NDC:55648-140-102 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
614 CAPSULE, DELAYED RELEASE (14 CAPSULE) in 1 BLISTER PACK
7NDC:55648-140-113 BLISTER PACK (3 BLISTER PACK) in 1 CARTON
714 CAPSULE, DELAYED RELEASE (14 CAPSULE) 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/FEIOperations
Wockhardt Limited916489953Manufacture

 
Wockhardt Limited

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Further information

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

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