Lansoprazole Delayed-release Capsules Usp, 15 Mg

Lansoprazole Delayed-release Capsules Usp, 15 Mg
SPL v2
SPL
SPL Set ID 7b248d72-45ba-478a-8e10-caff5919490f
Route
ORAL
Published
Effective Date 2012-02-16
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: W;140 Shape: capsule Color: pink Color: green Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2012-05-18

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
Section 42229-5

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.130212

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
  • 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.
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 1-800-346-6854

Poison Control Center:

Call 1-800-222-1222

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
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
Package Label.principal Display Panel
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
Section 42229-5 (42229-5)

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.130212

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
  • 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.
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 1-800-346-6854

Poison Control Center:

Call 1-800-222-1222

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
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
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
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

All Sections (JSON)