Lansoprazole LANSOPRAZOLE SAM'S WEST 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
FunFoxMeds bottle
Substance Lansoprazole
Route
ORAL
Applications
ANDA202194

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Lansoprazole USP 15 mg
Inactive Ingredients
Inactive ingredients FD&C Blue No. 2 gelatin hydroxypropyl cellulose iron oxide black iron oxide red iron oxide yellow low substituted hydroxypropyl cellulose magnesium carbonate methacrylic acid copolymer polyethylene glycol 6000 polysorbate 80 sodium lauryl sulphate starch (corn) sucrose sugar spheres talc titanium dioxide
Strengths
15 mg
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: RDY;398

Identifiers & Packaging

Container Type BOTTLE
UNII
0K5C5T2QPG
Packaging

Principal Display Panel Container : 14's count Principal Display Panel; Principal Display Panel Principal Display Panel

Package Descriptions
  • Principal Display Panel Container : 14's count Principal Display Panel
  • Principal Display Panel Principal Display Panel

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 days 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 dizzines s 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 healthcare 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)

Questions

Questions or comments? call 1-888-375-3784


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