lansoprazole LANSOPRAZOLE PUBLIX SUPER MARKETS INC FDA Approved 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
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Substance Lansoprazole
Route
ORAL
Applications
ANDA202319

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Lansoprazole 15 mg
Inactive Ingredients
Inactive ingredients D&C red no. 28 D&C yellow no. 10 FD&C blue no. 1 gelatin hypromellose low substituted hydroxypropyl cellulose mannitol meglumine methacrylic acid copolymer pharmaceutical ink polyethylene glycol polysorbate 80 sodium lauryl sulfate sugar spheres talc titanium dioxide Consumer Information Treats Frequent Heartburn Lansoprazole Delayed-Release Capsules 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 15 mg. Save for future reference. How Lansoprazole Delayed-Release Capsules 15 mg Treats Your Frequent Heartburn Lansoprazole Delayed-Release Capsules 15 mg stops acid production at the source – the pumps that release acid into the stomach. Lansoprazole Delayed-Release Capsules 15 mg is taken once a day (every 24 hours) every day for 14 days. What You Can Expect When Taking Lansoprazole Delayed-Release Capsules 15 mg Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole Delayed-Release Capsules 15 mg in the morning before eating. Lansoprazole Delayed-Release Capsules 15 mg is 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 15 mg every day for 14 days to treat your frequent heartburn. Who Should Take Lansoprazole Delayed-Release Capsules 15 mg 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 15 mg 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 15 mg 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 15 mg 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 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 a prescription drug. Acid reducers 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 right away (1-800-222-1222). 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 15 mg effectively treats frequent heartburn In three clinical studies Lansoprazole Delayed-Release Capsules 15 mg was shown to be significantly better than placebo in treating frequent heartburn. How Lansoprazole Delayed-Release Capsules 15 mg is Sold Lansoprazole Delayed-Release Capsules 15 mg is 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 15 mg Call 1-800-719-9260 Distributed By Perrigo® Allegan MI 49010 : 3T300 00 J6
Strengths
15 mg
Quantities
42 capsules
Treats Conditions
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
Pill Appearance
Shape: capsule Color: pink Imprint: L3T3

Identifiers & Packaging

Container Type UNKNOWN
UNII
0K5C5T2QPG
Packaging

Package/Label Principal Display Panel 24-HOUR lansoprazole DELAYED-RELEASE CAPSULES 15 mg ACID REDUCER Treats frequent heartburn May take 1 to 4 days for full effect Sodium free Actual Size 42 CAPSULES THREE-14-DAY COURSES OF TREATMENT Compare to the active ingredient in Prevacid® 24 HR 3t3-63-lansoprazole.jpg

Package Descriptions
  • Package/Label Principal Display Panel 24-HOUR lansoprazole DELAYED-RELEASE CAPSULES 15 mg ACID REDUCER Treats frequent heartburn May take 1 to 4 days for full effect Sodium free Actual Size 42 CAPSULES THREE-14-DAY COURSES OF TREATMENT Compare to the active ingredient in Prevacid® 24 HR 3t3-63-lansoprazole.jpg

Overview

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

Indications & Usage

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

Dosage & Administration

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. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 68-77°F (20-25°C) • keep product out of high heat and humidity • protect product from moisture • close cap tightly after use

Warnings & Precautions
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 a prescription drug. Acid reducers 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 right away (1-800-222-1222).
Purpose

Purpose Acid reducer

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.

Stop Use & Ask a Doctor

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

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 (1-800-222-1222).

Storage & Handling

Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 68-77°F (20-25°C) • keep product out of high heat and humidity • protect product from moisture • close cap tightly after use


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