LANSOPRAZOLE capsule, delayed release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
Available from:
HEB
Administration route:
ORAL
Prescription type:
OTC DRUG
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 - 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. - 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 - warfarin (blood-thinning medicine) - prescription antifungal or anti-yeast medicines - digoxin (heart medicine) - theophylline (asthma medicine) - tacrolimus or mycophenolate mofetil (immune system medicines) - atazanavir (medicine for HIV infection) - methotrexate (arthritis medicat
Authorization status:
Abbreviated New Drug Application
Authorization number:
37808-448-14, 37808-448-42

LANSOPRAZOLE- lansoprazole capsule, delayed release

HEB

----------

Lansoprazole Delayed-Release Capsules, USP

Drug Facts

Active ingredient (in each capsule)

Lansoprazole USP, 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 or mycophenolate mofetil (immune system medicines)

atazanavir (medicine for HIV infection)

methotrexate (arthritis medication)

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

you get diarrhea

you develop a rash or joint pain

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 at 1-800-222-1222.

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° to 25°C (68° to 77°F)

keep product out of high heat and humidity

protect product from moisture

close cap tightly after use

Inactive ingredients

acetone, D&C Red #28, D&C Yellow #10, FD&C Blue #1, gelatin, hypromellose, isopropyl alcohol,

light magnesium carbonate, methacrylic acid copolymer type C, polyethylene glycol 4000, polysorbate

80, sugar spheres (which contain sucrose and starch), talc, titanium dioxide. Printing Ink contains butyl

alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water,

shellac, strong ammonia solution, titanium dioxide

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday – Friday.

Principal Display Panel

Compare to the active ingredient in Prevacid 24 HR*

HEB

Treats Frequent Heartburn

Lansoprazole

Delayed-Release Capsules USP, 15 mg

Acid Reducer

24 Hour

May take 1 to 4 days for full effect

Sodium Free

Does not contain an ingredient derived from wheat, barley or rye

One 14-Day Course of Treatment

14 CAPSULES

LANSOPRAZOLE

lansoprazole capsule, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:378 0 8 -448

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

ACETO NE (UNII: 136 4PS73AF)

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

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

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

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

HYPRO MELLO SE 2 9 10 ( 5 MPA.S) (UNII: R75537T0 T4)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA)

METHACRYLIC ACID - ETHYL ACRYLATE CO PO LYMER ( 1:1) TYPE A (UNII: NX76 LV5T8 J)

PO LYETHYLENE GLYCO L 4 0 0 0 (UNII: 4R4HFI6 D9 5)

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

SUCRO SE (UNII: C151H8 M554)

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

BUTYL ALCO HO L (UNII: 8 PJ6 1P6 TS3)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SHELLAC (UNII: 46 N10 7B71O)

AMMO NIA (UNII: 5138 Q19 F1X)

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

Do es no t co ntain

WHEAT (UNII: 4J2I0 SN8 4Y)

Do es no t co ntain

BARLEY (UNII: 5PWM7YLI7R)

Do es no t co ntain

RYE (UNII: 0 R4AQI39 8 X)

Product Characteristics

Color

GREEN, PINK

S core

no sco re

S hap e

CAPSULE

S iz e

16 mm

Flavor

Imprint Code

L24HR

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:378 0 8 -448 -14

1 in 1 CARTON

12/0 3/20 18

1

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

2

NDC:378 0 8 -448 -42

3 in 1 CARTON

12/14/20 18

2

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

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 330 6

12/0 3/20 18

Labeler -

HEB (007924756)

Registrant -

T eva Pharmaceuticals USA, Inc. (001627975)

Revised: 4/2019

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