Omeprazole OMEPRAZOLE A-S MEDICATION SOLUTIONS 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 Omeprazole
Route
ORAL
Applications
ANDA211732
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide crospovidone glyceryl monostearate hypromellose hydroxypropyl cellulose iron oxide red magnesium stearate methacrylic acid copolymer polyethylene glycol polysorbate 80 silicified microcrystalline cellulose sodium hydroxide sodium lauryl sulphate starlac (contains lactose monohydrate and corn starch) sugar spheres (contains sucrose and corn starch) talc titanium dioxide triethyl citrate.
Strengths
20 mg 20.6 mg
Quantities
14 tablet
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: pink Imprint: H;O9

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
KG60484QX9
Packaging

HOW SUPPLIED Product: 50090-6888 NDC: 50090-6888-0 14 TABLET, DELAYED RELEASE in a BOTTLE / 2 in a CARTON; Omeprazole Label Image

Package Descriptions
  • HOW SUPPLIED Product: 50090-6888 NDC: 50090-6888-0 14 TABLET, DELAYED RELEASE in a BOTTLE / 2 in a CARTON
  • Omeprazole Label Image

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 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 allergy reaction occurs, stop use and seek medical help right away.
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.


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