LANSOPRAZOLE- lansoprazole capsule 
Reliable 1 Laboratories

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Reliable-1 Lansoprazole15mg

Drug Facts

Active ingredient (in each capsule)

Lansoprazole USP, 15 mg

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 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 professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Posion Control Center right away (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 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 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

FD&C Blue No.2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide

Questions or comments?

call 1-888-375-3784

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 wheesing, particulary with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

NDC 69618-055-42

Compare to the active ingredient in Prevacid 24HR Capsules

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Reliable-1 Laboratories

Lansoprazole

Delayed-Release Capsules, USP 15 mg

Acid Reducer

24 HR

42 Capsules

Three 14-Day Cources of Treatment

Carton

LANSOPRAZOLE 
lansoprazole capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-055
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SUCROSE (UNII: C151H8M554)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
GELATIN (UNII: 2G86QN327L)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White to pale yellow colored enteric coated pellets filled in black color banded, Size “3” hard gelatin capsules with opaque pink colored cap and opaque green colored body) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code RDY;398
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69618-055-423 in 1 CARTON; Type 0: Not a Combination Product09/20/201904/30/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20219409/20/201904/30/2021
Labeler - Reliable 1 Laboratories (079718111)

Revised: 8/2021
 
Reliable 1 Laboratories