Lansoprazole description, usages, side effects, indications, overdosage, supplying and lots more!

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Lansoprazole

QUALITY CHOICE (Chain Drug Marketing Association)
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




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 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in PREVACID®24HR

Heartburn Relief 24 Hour™

Acid Reducer

Lansoprazole Delayed-Release Capsules, 15 mg

Clinically Proven Relief: To Treat Frequent Heartburn

May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

Sodium Free

Capsules

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI  48376-0995

www.qualitychoice.com

Product of India

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.

Product Label

Lansoprazole
Quality Choice Heartburn Relief 24 HR Capsule

Lansoprazole

Lansoprazole CAPSULE, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-008
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
lansoprazole LANSOPRAZOLE 15 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
GREEN 16 mm W140 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 14 in 1 BOTTLE
2 14 in 1 BOTTLE
3 NDC:63868-008-42 3 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202727 2013-04-30


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Be sure to consult your doctor before taking any medication!
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