LANSOPRAZOLE

Main information

  • Trade name:
  • LANSOPRAZOLE- lansoprazole capsule, delayed release
  • Composition:
  • LANSOPRAZOLE 15 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LANSOPRAZOLE- lansoprazole capsule, delayed release
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Acid reducer - 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

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 64679-140-00, 64679-140-01, 64679-140-07, 64679-140-08, 64679-140-09, 64679-140-10, 64679-140-11
  • Last update:
  • 02-06-2019

Summary of Product characteristics: dosage, interactions, side effects

LANSOPRAZOLE- lansoprazole capsule, delayed release

Wockhardt USA LLC.

----------

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

LANSOPRAZOLE

lansoprazole capsule, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 46 79 -140

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LANSO PRAZO LE (UNII: 0 K5C5T2QPG) (LANSOPRAZOLE - UNII:0 K5C5T2QPG)

LANSOPRAZOLE

15 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN (UNII: 2G8 6 QN327L)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA)

PO LYETHYLENE GLYCO L 6 0 0 0 (UNII: 30 IQX730 WE)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

SUCRO SE (UNII: C151H8 M554)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

METHACRYLIC ACID - METHYL METHACRYLATE CO PO LYMER ( 1:1) (UNII: 74G4R6 TH13)

Product Characteristics

Color

PINK (Opaque dark pink cap) , GREEN (Opaque dark green bo dy)

S core

no sco re

S hap e

CAPSULE

S iz e

16 mm

Flavor

Imprint Code

W;140

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 46 79 -140 -0 0

450 0 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 5/18 /20 12

2

NDC:6 46 79 -140 -0 1

1 in 1 CARTON

0 5/18 /20 12

2

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:6 46 79 -140 -0 8

2 in 1 CARTON

0 5/18 /20 12

3

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:6 46 79 -140 -0 9

3 in 1 CARTON

0 5/18 /20 12

4

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

5

NDC:6 46 79 -140 -0 7

1 in 1 CARTON

0 5/18 /20 12

5

14 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

6

NDC:6 46 79 -140 -10

2 in 1 CARTON

0 5/18 /20 12

6

14 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

7

NDC:6 46 79 -140 -11

3 in 1 CARTON

0 5/18 /20 12

7

14 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Wockhardt USA LLC.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 2727

0 5/18 /20 12

Labeler -

Wockhardt USA LLC. (170508365)

Registrant -

Wockhardt USA LLC. (170508365)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Wo c kha rdt

Limite d

9 16 48 9 9 53

ANALYSIS(6 46 79 -140 ) , LABEL(6 46 79 -140 ) , MANUFACTURE(6 46 79 -140 ) , PACK(6 46 79 -

140 )

Revised: 12/2018