Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ff3d9fc7-4075-4d97-ade5-155ce818edae
Route
ORAL
Published
Effective Date 2013-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lansoprazole (15 mg)
Inactive Ingredients
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)

Identifiers & Packaging

Pill Appearance
Imprint: w140 Shape: capsule Color: pink Color: green Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2013-03-27

Description

Lansoprazole 15 mg

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Lansoprazole 15 mg

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

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.
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.
Product Label
Lansoprazole delayed release capsules 15 mg
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® 24 HR*

*Prevacid® 24 HR is a registered trademark of Takeda Pharmaceuticals North America, Inc., and is used under license. ©2012 Novartis Consumer Health. Inc

HEARTBURN RELIEF 24 HOUR™

Lansoprazole Delayed- Release capsules, 15 mg

  • 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

ACID REDUCER

Sodium Free

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.

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.

Active Ingredient (in Each Capsule)

Lansoprazole 15 mg

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)

Structured Label Content

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
Purpose

Acid reducer

Warnings (WARNINGS)

Allergy alert: Do not use if you are allergic to lansoprazole

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.
Do Not Use (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.
Product Label
Lansoprazole delayed release capsules 15 mg
Other Information (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 (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? (Questions or comments?)

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

Principal Display Panel

Compare to the active ingredient in Prevacid® 24 HR*

*Prevacid® 24 HR is a registered trademark of Takeda Pharmaceuticals North America, Inc., and is used under license. ©2012 Novartis Consumer Health. Inc

HEARTBURN RELIEF 24 HOUR™

Lansoprazole Delayed- Release capsules, 15 mg

  • 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

ACID REDUCER

Sodium Free

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.

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Lansoprazole 15 mg

Ask A Doctor Before Use If You Have (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 (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)

Advanced Ingredient Data


Raw Label Data

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