Active Ingredient (In Each Capsule)
Lansoprazole USP, 15 mg
Lansoprazole
FDA Label NDC 68196-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sam's West, Inc. for the product Lansoprazole (NDC 68196-030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, use, allergy alert:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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 or mycophenolate mofetil (immune system medicines)
- atazanavir (medicine for HIV infection)
- methotrexate (arthritis medicine)
- presently taking a prescription drug. Antacids may interact with certain prescription drugs.
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
- you develop a rash or joint pain
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 (1-800-222-1222) 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
- 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
- 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.
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
Other Information
- read the directions, warnings and package insert before use
- keep the package 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
- close cap tightly after use
Inactive Ingredients
black iron oxide, colloidal silicon dioxide, corn starch, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide, yellow iron oxide
Questions Or Comments?
1-877-446-3679 (1-877-4-INFO-RX).
Consumer Information
Treats Frequent Heartburn
LANSOPRAZOLE DELAYED-RELEASE CAPSULES, USP
(lan soe′ pra zole)
15 mg
Acid Reducer
• May take 1 to 4 days for full effect
• Sodium Free
Please read the entire package insert before taking lansoprazole delayed-release capsules.
Save for future reference.
How Lansoprazole Delayed-Release Capsules Treat Your Frequent Heartburn
Lansoprazole delayed-release capsules stop acid production at the source – the pumps that release acid into the stomach. Lansoprazole delayed-release capsules are taken once a day (every 24 hours), every day for 14 days.
What You Can Expect When Taking Lansoprazole Delayed-Release Capsules
Frequent heartburn can occur anytime during the 24-hour period (day or night). Take lansoprazole delayed-release capsules in the morning before eating. Lansoprazole delayed-release capsules are clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take lansoprazole delayed-release capsules every day for 14 days to treat your frequent heartburn.
Who Should Take Lansoprazole Delayed-Release Capsules
Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.
Who Should NOT Take Lansoprazole Delayed-Release Capsules
People who have one episode of heartburn a week or less, or who want immediate relief of heartburn.
How to Take Lansoprazole Delayed-Release Capsules 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.
When to Take Lansoprazole Delayed-Release Capsules Again
You may repeat a 14-day course of therapy every 4 months.
When to Talk to Your Doctor
Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.
Warnings and When to Ask Your Doctor
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 your 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 or mycophenolate mofetil (immune system medicines)
• atazanavir (medicine for HIV infection)
• methotrexate (arthritis medicine)
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
• you develop a rash or joint pain
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 (1-800-222-1222) right away.
Tips for Managing Heartburn
• Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
• Eat slowly and do not eat big meals.
• Do not eat late at night or just before bedtime.
• Do not lie flat or bend over soon after eating.
• Raise the head of your bed.
• Wear loose-fitting clothing around your stomach.
• If you are overweight, lose weight.
• If you smoke, quit smoking.
Clinical studies prove lansoprazole delayed-release capsules effectively treat frequent heartburn
In three clinical studies, lansoprazole delayed-release capsules were shown to be significantly better than placebo in treating frequent heartburn.
How Lansoprazole Delayed-Release Capsules are Sold
Lansoprazole delayed-release capsules are available in 14 capsule, 28 capsule and 42 capsule sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.
For Questions or Comments About Lansoprazole Delayed-Release Capsules
Call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
Revised: 4/2018
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Compare to Prevacid® 24HR active ingredient*
NDC 68196-030-03
Member's MarkTM
24 hour
Lansoprazole Delayed-Release Capsules, USP 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
Value 3 Pack
actual size
42 Capsules
Three 14-day courses of treatment
KEEP THE PACKAGE AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.
TAMPER-EVIDENT BOTTLE. DO NOT USE IF TAMPER-EVIDENT INNER OR BLACK BAND AROUND THE CENTER OF EACH CAPSULE IS MISSING OR BROKEN.
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Prevacid® 24HR.
LABORATORY TESTED - QUALITY ASSURED
GLUTEN FREE
100% MONEY BACK GUARANTEE
QUALITY AND PERFORMANCE
We would like to hear from you with any comments or suggestions.
In the continental U.S. or Canada, you can call us at 1-877-446-3679 (1-877-4-INFO-RX)
from 7:30 a.m. to 5 p.m. ET Monday - Friday.
DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE, AR 72716
Dp23446 Lansoprazole Dr Capsules Usp 15 mg (Lansoprazole Dr Capsules Usp 15 mg 1)
* Please review the disclaimer below.
