Omeprazole 20 mg OMEPRAZOLE MARKSANS PHARMA LIMITED FDA Approved USE(S) Uses • 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
Route
ORAL
Applications
ANDA218829

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT(S) Active ingredient (in each tablet) Omeprazole USP 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Inactive Ingredients
INACTIVE INGREDIENTS Inactive ingredients colloidal silicone dioxide crospovidone glyceryl monostearate hydroxypropyl cellulose hypromellose magnesium stearate methacrylic acid and ethyl acrylate copolymer microcrystalline cellulose polyethylene glycol 400 polyethylene glycol 6000 polysorbate 80 red iron oxide simethicone sodium stearyl fumarate starch sucrose talc titanium dioxide triethyl citrate
Strengths
20 mg 20.6 mg
Treats Conditions
Use S Uses 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: pink Imprint: 91

Identifiers & Packaging

Container Type BOTTLE
UPC
0325000091767 0325000091774
UNII
426QFE7XLK
Packaging

PRINCIPAL DISPLAY PANEL NDC: 25000-091-76 Omeprazole Delayed-Release Tablets 20 mg 14's count Carton NDC: 25000-091-76 Omeprazole Delayed-Release Tablets 20 mg 14's count Label NDC: 25000-091-77 Omeprazole Delayed-Release Tablets 20 mg 14's count (2 x 7's blister) Carton omeprazole-14s-blister-carton omeprazole-14s-bottle-pack-label omeprazole-14s-blisterpack-carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC: 25000-091-76 Omeprazole Delayed-Release Tablets 20 mg 14's count Carton NDC: 25000-091-76 Omeprazole Delayed-Release Tablets 20 mg 14's count Label NDC: 25000-091-77 Omeprazole Delayed-Release Tablets 20 mg 14's count (2 x 7's blister) Carton omeprazole-14s-blister-carton omeprazole-14s-bottle-pack-label omeprazole-14s-blisterpack-carton

Overview

USE(S) Uses • 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(S) Uses • 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 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 Warnings Allergy alert: Do not use if you are allergic to Omeprazole Omeprazole may cause severe skin reactions. Symptoms include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical attention right away.
Purpose

PURPOSE Purpose Acid reducer

Do Not Use

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 DOCTOR IF 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 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

STORAGE Other information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F) and protect from moisture


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