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| Product NDC Code | 68391-117 | ||||
|---|---|---|---|---|---|
| Drug Name | Berkley and jensen lansoprazole |
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| Type | Brand | ||||
| Pharm Class | Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, DELAYED RELEASE | ||||
| RxCUI drug identifier | 596843 | ||||
| Application Number | ANDA202319 | ||||
| Labeler Name | BJWC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each capsule) Lansoprazole 15 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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 Questions or comments? 1-800-934-1204 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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Information about the drug product’s indications for use.Purpose Acid Reducer
Spl product data elements
Usually a list of ingredients in a drug product.Berkley and Jensen Lansoprazole Lansoprazole LANSOPRAZOLE LANSOPRAZOLE D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MANNITOL MEGLUMINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE L3T3
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Principal Display Panel Compare to the active ingredient in Prevacid ® 24 HR 24 HR LANSOPRAZOLE DELAYED-RELEASE CAPSULES, 15mg ACID REDUCER MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT SODIUM FREE TREATS FREQUENT HEARTBURN ACTUAL SIZE 100% MONEY-BACK GUARANTEE GLUTEN FREE SODIUM FREE THREE 14-DAY COURSES OF TREATMENT 3 BOTTLES – 14 CAPSULES EACH 42 TOTAL CAPSULES Lansoprazole Delayed-Release Capsules, 15mg Carton Image 1 Lansoprazole Delayed-Release Capsules, 15mg Carton Image 2
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are • taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-934-1204
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API