LANSOPRAZOLE 24 HR- lansoprazole capsule, delayed release 
Lannett Company, Inc.

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Drug Facts

Active ingredient

Lansoprazole 15mg

Purpose

Acid reducer

Uses

? 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 a prescription drug. Acid reducers may interact with certain prescription drugs.



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 care 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 Course of Treatment (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

? close cap tightly after use

Inactive Ingredients

ammonium hydroxide, black iron oxide, butyl alcohol, dehydrated alcohol, FD&C Blue #1, FD&C Red #40, gelatin, hypromellose, iron oxide yellow, isopropyl alcohol, magnesium carbonate, mannitol, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, sodium starch glycolate, sugar sphere, talc, titanium dioxide

Questions or Comments

1-844-834-0530

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

CIA79102B

Rev. 09/20

Package/Label Principal Display Panel

Carton
LANSOPRAZOLE  24 HR
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62175-515
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
MANNITOL (UNII: 3OWL53L36A)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (opaque green cap) , WHITE (opague white body) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code KU;515
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62175-515-241 in 1 CARTON09/29/2017
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62175-515-122 in 1 PACKAGE, COMBINATION09/29/2017
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:62175-515-523 in 1 PACKAGE, COMBINATION09/29/2017
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20715709/29/2017
Labeler - Lannett Company, Inc. (006422406)

Revised: 9/2020
Document Id: 9d4be625-fedb-4b0a-bfcf-b8b513eeec8c
Set id: b5b4e61e-91c5-41bd-a16d-e25d9be2c87e
Version: 15
Effective Time: 20200910
 
Lannett Company, Inc.