Lansoprazole Delayed-Release Capsules USP, 15 mg

Lansoprazole Delayed-Release Capsules USP, 15 mg

Drug Labeling and Warnings

Drug Details

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LANSOPRAZOLE- lansoprazole capsule, delayed release 
Wockhardt USA LLC.

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Lansoprazole Delayed-Release Capsules USP, 15 mg

OTC - ACTIVE INGREDIENT SECTION

Lansoprazole 15 mg

OTC - PURPOSE SECTION

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.

OTC - 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 INGREDIENT

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

OTC - QUESTIONS

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

NDC: 64679-140-01

15 mg

14 C pack

15 mg label
LANSOPRAZOLE 
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
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: 64679-140-004500 in 1 POUCH; Type 0: Not a Combination Product05/18/2012
2NDC: 64679-140-011 in 1 CARTON05/18/2012
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 64679-140-082 in 1 CARTON05/18/2012
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 64679-140-093 in 1 CARTON05/18/2012
414 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 64679-140-071 in 1 CARTON05/18/2012
514 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC: 64679-140-102 in 1 CARTON05/18/2012
614 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC: 64679-140-113 in 1 CARTON05/18/2012
714 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20272705/18/2012
Labeler - Wockhardt USA LLC. (170508365)
Registrant - Wockhardt USA LLC. (170508365)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited916489953ANALYSIS(64679-140) , LABEL(64679-140) , MANUFACTURE(64679-140) , PACK(64679-140)

Revised: 12/2018
 
Wockhardt USA LLC.


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