Good Sense Omeprazole and Sodium Bicarbonate OMEPRAZOLE SODIUM BICARBONATE L. PERRIGO COMPANY 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
ANDA201361
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each capsule) Omeprazole 20 mg Sodium Bicarbonate 1100 mg
Inactive Ingredients
Inactive ingredients FD&C blue no. 1 FD&C blue no. 2 aluminum lake FD&C red no. 40 gelatin polysorbate 80 sodium lauryl sulfate sodium starch glycolate sodium stearyl fumarate titanium dioxide
Strengths
20 mg 1100 mg
Quantities
42 capsules 3 bottles
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: white Imprint: 732

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
KG60484QX9 8MDF5V39QO
Packaging

Package/Label Principal Display Panel Treats Frequent Heartburn Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg Acid Reducer Allows Absorption of this Omeprazole Product Compare to active ingredients of Zegerid OTC ® 100% SATISFACTION GUARANTEED 42 Capsules Three 14-Day Courses of Treatment Package Contains 3 Bottles 732-c2-92-omeprazole-and-sodium-bicarbonate-1.jpg 732-c2-92-omeprazole-and-sodium-bicarbonate-2.jpg

Package Descriptions
  • Package/Label Principal Display Panel Treats Frequent Heartburn Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg Acid Reducer Allows Absorption of this Omeprazole Product Compare to active ingredients of Zegerid OTC ® 100% SATISFACTION GUARANTEED 42 Capsules Three 14-Day Courses of Treatment Package Contains 3 Bottles 732-c2-92-omeprazole-and-sodium-bicarbonate-1.jpg 732-c2-92-omeprazole-and-sodium-bicarbonate-2.jpg

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, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • do not chew or crush the capsule • do not open capsule and sprinkle on food • 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. 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 Allows absorption of this omeprazole product

Do Not Use

Do not use if you have: • trouble or pain swallowing food • vomiting with blood • 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).

Storage & Handling

Other information • each capsule contains: sodium 303 mg • read the directions, warnings and accompanying label information before use • store at 20-25 o C (68-77 o F) • tamper-evident: do not use if the band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing. • keep product out of high heat and humidity • protect product from moisture

Questions

Questions or comments? 1-800-719-9260


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