Zegerid OTC OMEPRAOLE SODIUM BICARBONATE RILEY CONSUMER CARE 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
ANDA201361

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
14 capsules
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

Identifiers & Packaging

Container Type BOX
UNII
KG60484QX9 8MDF5V39QO
Packaging

Package/Label Principal Display Panel CLINICALLY PROVEN TO Treat Frequent Heartburn Zegerid OTC ® Omeprazole & Sodium Bicarbonate Capsules 20 mg / 1100 mg ACID REDUCER / ALLOWS ABSORPTION OF THIS OMEPRAZOLE PRODUCT 14 CAPSULES 24 HOUR One 14-Day Course of Treatment MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT zegerid-omeprazole-&-sodium-bicarbonate-carton-image.jpg

Package Descriptions
  • Package/Label Principal Display Panel CLINICALLY PROVEN TO Treat Frequent Heartburn Zegerid OTC ® Omeprazole & Sodium Bicarbonate Capsules 20 mg / 1100 mg ACID REDUCER / ALLOWS ABSORPTION OF THIS OMEPRAZOLE PRODUCT 14 CAPSULES 24 HOUR One 14-Day Course of Treatment MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT zegerid-omeprazole-&-sodium-bicarbonate-carton-image.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 (in 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 • a sodium-restricted diet 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 Allows absorption of this omeprazole product

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).

Questions

Questions or comments? Call 1-888-4-ZEG-OTC (1-888-493-4682) between 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday


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