LANSOPRAZOLE capsule, delayed release

Lansoprazole by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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

NDC: 64679-140-01

15 mg

14 C pack

INGREDIENTS AND APPEARANCE

LANSOPRAZOLE 
lansoprazole capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64679-140
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)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
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
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: 64679-140-00	4500 in 1 POUCH; Type 0: Not a Combination Product	05/18/2012
2	NDC: 64679-140-01	1 in 1 CARTON	05/18/2012
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 64679-140-08	2 in 1 CARTON	05/18/2012
3		14 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 64679-140-09	3 in 1 CARTON	05/18/2012
4		14 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 64679-140-07	1 in 1 CARTON	05/18/2012
5		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 64679-140-10	2 in 1 CARTON	05/18/2012
6		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 64679-140-11	3 in 1 CARTON	05/18/2012
7		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Labeler - Wockhardt USA LLC. (170508365)

Registrant - Wockhardt USA LLC. (170508365)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		916489953	ANALYSIS(64679-140) , LABEL(64679-140) , MANUFACTURE(64679-140) , PACK(64679-140)