Leader Omeprazole OMEPRAZOLE CARDINAL HEALTH 110, LLC. DBA LEADER 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 Omeprazole
Route
ORAL
Applications
NDA209400

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Omeprazole 20 mg
Inactive Ingredients
Inactive ingredients amino methacrylate copolymer ascorbic acid cetyl alcohol colloidal silicon dioxide crospovidone ferric oxide flavor hypromellose hypromellose phthalate maize maltodextrin mannitol microcrystalline cellulose propylene glycol silicon dioxide sodium stearate sodium stearyl fumarate sorbitol sucralose sugar spheres talc titanium dioxide triethyl citrate
Strengths
20 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: red Imprint: 20

Identifiers & Packaging

Container Type BOX
UNII
KG60484QX9
Packaging

Package/Label Principal Display Panel 24 HR Omeprazole Delayed Release Orally Disintegrating Tablets, 20 mg Acid Reducer MELTech ™ Melts In Your Mouth Treats Frequent Heartburn! Melts in Your Mouth Dissolves Without Water Strawberry Flavor 42 TABLETS Three 14-Day Courses Of Treatment Actual Size COMPARE TO PRILOSEC OTC ® 100% Money Back Guarantee Leader Omeprazole Strawberry Carton Image 1 of 2 Leader Omeprazole Strawberry Carton Image 2 of 2

Package Descriptions
  • Package/Label Principal Display Panel 24 HR Omeprazole Delayed Release Orally Disintegrating Tablets, 20 mg Acid Reducer MELTech ™ Melts In Your Mouth Treats Frequent Heartburn! Melts in Your Mouth Dissolves Without Water Strawberry Flavor 42 TABLETS Three 14-Day Courses Of Treatment Actual Size COMPARE TO PRILOSEC OTC ® 100% Money Back Guarantee Leader Omeprazole Strawberry Carton Image 1 of 2 Leader Omeprazole Strawberry Carton Image 2 of 2

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 • for 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; 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 omeprazole
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 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

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 and warnings before use • keep the carton. It contains important information. • store at 20-25°C (68-77°F); keep product out of high heat and moisture

Questions

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


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