LANSOPRAZOLE capsule, delayed release

Lansoprazole by

Drug Labeling and Warnings

Lansoprazole by is a Otc medication manufactured, distributed, or labeled by Wockhardt Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

LANSOPRAZOLE 
lansoprazole capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55648-140
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)	LANSOPRAZOLE	15 mg

Inactive Ingredients
Ingredient Name	Strength
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)
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
Color	PINK (Opaque dark pink cap) , GREEN (Opaque dark green body)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	W;140
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55648-140-00	4500 in 1 POUCH
2	NDC: 55648-140-01	1 in 1 CARTON
2		14 in 1 BOTTLE
3	NDC: 55648-140-08	2 in 1 CARTON
3		14 in 1 BOTTLE
4	NDC: 55648-140-09	3 in 1 CARTON
4		14 in 1 BOTTLE
5	NDC: 55648-140-07	1 in 1 CARTON
5		14 in 1 BLISTER PACK
6	NDC: 55648-140-10	2 in 1 CARTON
6		14 in 1 BLISTER PACK
7	NDC: 55648-140-11	3 in 1 CARTON
7		14 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202727	05/18/2012

Labeler - Wockhardt Limited (650069115)

Registrant - Wockhardt Limited (650069115)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		916489953	Manufacture