Lansoprazole

P and L Development of New York Corporation
P and L Development of New York Corporation

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each capsule)
• Purpose
• Use
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Lansoprazole Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel
• Product Label

FULL PRESCRIBING INFORMATION

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.

Lansoprazole 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?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Prevacid® 24HR

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

CAPSULES

Sodium Free

KEEP OUTER 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.

*This product is not manufactured or distributed by Takeda Pharmaceuticals North America, Inc., owner of the registered trademark Prevacid®, or by Novartis Consumer Health, Inc., distributor of the Prevacid®24HR product.

Distributed by:

PL Developments

Westbury, NY  11590

Product of India

Product Label