Lansoprazole Lansoprazole LANSOPRAZOLE LANSOPRAZOLE FERROSOFERRIC OXIDE SILICON DIOXIDE STARCH, CORN FD&C BLUE NO. 1 FD&C RED NO. 3 FD&C RED NO. 40 GELATIN HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM CARBONATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SHELLAC AMMONIA SUCROSE TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW MYL;LD15
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel Compare to the active ingredient in Prevacid® 24HR† Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect Sodium free Capsules Three 14-day Course of Treatment †This product is not manufactured or distributed by Takeda Pharmaceuticals North America, Inc., owner of the registered trademark Prevacid®, or by GSK Consumer Healthcare, distributor of the Prevacid® 24HR product. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP OR BLACK BAND AROUND THE CENTER OF EACH CAPSULES IS BROKEN OR MISSING. KEEP OUTER CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI48152 www.rugbylaboratories.com; Package Label RUGBY Lansoprazole Delayed-Release Capsules Lansoprazole USP, 15 mg
- Principal Display Panel Compare to the active ingredient in Prevacid® 24HR† Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect Sodium free Capsules Three 14-day Course of Treatment †This product is not manufactured or distributed by Takeda Pharmaceuticals North America, Inc., owner of the registered trademark Prevacid®, or by GSK Consumer Healthcare, distributor of the Prevacid® 24HR product. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP OR BLACK BAND AROUND THE CENTER OF EACH CAPSULES IS BROKEN OR MISSING. KEEP OUTER CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI48152 www.rugbylaboratories.com
- Package Label RUGBY Lansoprazole Delayed-Release Capsules Lansoprazole USP, 15 mg
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.
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 warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines digoxin (heart medicine) theophylline (asthma medicine) tacrolimus or mycophenolate mofetil (immune system medicine) 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.
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 (1-800-222-1222) right away.
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 20°-25°C (68°-77°F) keep product out of high heat and humidity protect product from moisture close cap tightly after use
Questions
Questions or comments? Call 1-800-645-2158
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