Your browser does not support JavaScript! LANSOPRAZOLE CAPSULE, DELAYED RELEASE [RUGBY LABORATORIES INC]
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RxNorm Names

LANSOPRAZOLE capsule, delayed release
[Rugby Laboratories Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (in each capsule)

Lansoprazole 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 (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
  • you get diarrhea

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.

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. Patients should use the lowest dose and shortest duration of this therapy.
  • 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 ingredients

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

Questions or comments?

1-800-645-2158

Principal Display Panel

Heartburn Relief 24 Hour™

Lansoprazole Delayed-Release Capsules, 15 mg

ACID REDUCER

  • May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
  • Clinically proven to treat frequent heartburn

Sodium Free

COMPARE TO ACTIVE INGREDIENT IN PREVACID® 24 HR*

CAPSULES

*Rugby Laboratories is not affiliated with the owner of the trademark Prevacid® 24 HR.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

Product of India

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

TAMPER-EVIDENT BOTTLE: DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” OR DARK BLUE TO BLACK GELATIN BAND AROUND THE CENTER OF EACH CAPSULE IS MISSING OR BROKEN.

Package Label

Lansoprazole 15 mg

Rugby Lansoprazole Capsule

LANSOPRAZOLE 
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-4122(NDC:55648-140)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYPROMELLOSES 
MAGNESIUM CARBONATE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
SILICON DIOXIDE 
STARCH, CORN 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
Product Characteristics
ColorPINK, GREENScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code W140
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-4122-881 in 1 CARTON
114 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20272705/18/2012
Labeler - Rugby Laboratories Inc (191427277)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
 
Rugby Laboratories Inc

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