Lansoprazole LANSOPRAZOLE CVS PHARMACY 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
NDA208025

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Lansoprazole 15 mg
Inactive Ingredients
Inactive ingredients ascorbic acid cetyl alcohol colloidal silicon dioxide copovidone crospovidone flavor hypromellose hypromellose phthalate maize maltodextrin maltitol mannitol meglumine microcrystalline cellulose polysorbate 80 propylene glycol silicon dioxide sodium stearyl fumarate sorbitol sucralose sugar spheres talc titanium dioxide triethyl citrate
Strengths
15 mg
Quantities
42 tablets
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: round Color: white Imprint: 15

Identifiers & Packaging

Container Type BOX
UNII
0K5C5T2QPG
Packaging

Package/Label Principal Display Panel CVS Health ® Compare to the active ingredient in Prevacid ® 24HR Treats Frequent Heartburn Lansoprazole Melts in your mouth dissolves without water DELAYED RELEASE ORALLY DISINTEGRATING TABLETS 15 mg 15 Actual Size Acid Reducer May take 1 to 4 days for full effect 24 HR Strawberry Flavor 42 TABLETS Three 14-day courses of treatment MELTech ® Melts In Your Mouth cvs-lasoprazole-strawberry-carton-image-1.jpg cvs-lasoprazole-strawberry-carton-image-2.jpg

Package Descriptions
  • Package/Label Principal Display Panel CVS Health ® Compare to the active ingredient in Prevacid ® 24HR Treats Frequent Heartburn Lansoprazole Melts in your mouth dissolves without water DELAYED RELEASE ORALLY DISINTEGRATING TABLETS 15 mg 15 Actual Size Acid Reducer May take 1 to 4 days for full effect 24 HR Strawberry Flavor 42 TABLETS Three 14-day courses of treatment MELTech ® Melts In Your Mouth cvs-lasoprazole-strawberry-carton-image-1.jpg cvs-lasoprazole-strawberry-carton-image-2.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 • take 1 tablet before eating in the morning • do not crush or chew tablets • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water. • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • do not take this medicine with alcohol Repeated 14-Day Course (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. • lansoprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • 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 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. • 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.
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 • 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 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

Questions

Questions or comments? 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST


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