Omeprazole OMEPRAZOLE LIVING BETTER BRANDS LLC 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
ANDA207891

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Omeprazole USP 20 mg
Inactive Ingredients
Inactive ingredients anhydrous lactose hypromellose hypromellose acetate succinate iron oxide red iron oxide yellow lactose monohydrate methyl cellulose monoethanolamine propylene glycol sodium lauryl sulfate sodium starch glycolate sodium stearate sodium stearyl fumarate talc triethyl citrate and titanium dioxide. The imprinting ink contains ammonium hydroxide black iron oxide n-butyl alcohol propylene glycol and shellac.
Strengths
20 mg
Quantities
14 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: oval Color: brown Imprint: 20

Identifiers & Packaging

Container Type BOX
UNII
KG60484QX9
Packaging

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton COMPARE TO Prilosec OTC ® * NDC 21130-991-14 Signature SELECT ® OMEPRAZOLE 24 HR | TREATS FREQUENT HEARTBURN Delayed-Release Tablets 20 mg Acid Reducer SWALLOW-DO NOT CHEW Actual Size 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton COMPARE TO Prilosec OTC ® * NDC 21130-991-14 Signature SELECT ® OMEPRAZOLE 24 HR | TREATS FREQUENT HEARTBURN Delayed-Release Tablets 20 mg Acid Reducer SWALLOW-DO NOT CHEW Actual Size 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton

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 swallow 1 tablet with a glass of water before eating in the morning 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 swallow whole. Do not chew or crush tablets. 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. 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. omeprazole 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 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. 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 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

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 to 25° C (68 to 77° F) and protect from moisture

Questions

Questions or Comments? Call toll free 1-800-818-4555 weekdays.


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