Label: ZEGERID OTC- omeprazole, sodium bicarbonate capsule
- NDC Code(s): 82632-100-01, 82632-100-03
- Packager: Riley Consumer Care LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 24, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Use
- Warnings
-
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
- ASK DOCTOR/PHARMACIST
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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.
-
Other information
- each capsule contains: sodium 303 mg
- read the directions, warnings and accompanying label information before use
- store at 20°- 25°C (68°-77°F)
- tamper-evident: do not use if the blue band around the capsule is missing or broken. Do not use if foil inner seal imprinted with "Sealed for your protection" is missing, open or broken.
- keep product out of high heat and humidity
- protect product from moisture
- Inactive Ingredients
-
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
Zegerid OTC design logo is a registered trademark of Riley Consumer Care, LLC d/b/a Carlin Consumer Health
Zegerid OTC is a registered trademark of Santarus, Inc.
Dist by: Riley Consumer Care, LLC d/b/a Carlin Consumer Health
New York, NY 10151 -
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN
Zegerid OTC works differently from other OTC heartburn products, such as antacids and other
acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces
stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days.
TIIPS FOR MANAGING HEARTBURN - Do not lie flat or bend over after eating
- Do not eat late at night or just before bedtime
- Certain foods or drinks are more likely to cause heartburn,
such as rich, spicy, fatty and fried foods, chocolate, caffeine,
alcohol and even some fruits and vegetables
- Eat slowly and do not eat big meals
- If you are overweight, lose weight
- If you smoke, quit smoking
- Raise the head of your bed
- Wear loose-fitting clothing around your stomach
CLINICALLY PROVEN TO
Treat Frequent Heartburn
Zegerid
OTC®
- Omperazole 20mg / Acid Reducer
-
Sodium Bicarbonate 1100mg
/Allows Absorption of this
Omperazole Product
14 CAPSULES
One 14-Day Course of Treatment
MAY TAKE 1 TO 14 DAYS FOR FULL EFFECT
24 HOUR
1H9D5 XL C1 -
INGREDIENTS AND APPEARANCE
ZEGERID OTC
omeprazole, sodium bicarbonate capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82632-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Omeprazole (UNII: KG60484QX9) (Omeprazole - UNII:KG60484QX9) Omeprazole 20 mg Sodium Bicarbonate (UNII: 8MDF5V39QO) (Sodium Cation - UNII:LYR4M0NH37) Sodium Bicarbonate 1100 mg Inactive Ingredients Ingredient Name Strength Fd&C Blue No. 1 (UNII: H3R47K3TBD) Fd&C Blue No. 2 Aluminum Lake (UNII: 4AQJ3LG584) Fd&C Red No. 40 (UNII: WZB9127XOA) Gelatin, Unspecified (UNII: 2G86QN327L) Polysorbate 80 (UNII: 6OZP39ZG8H) Sodium Lauryl Sulfate (UNII: 368GB5141J) Sodium Starch Glycolate Type A (UNII: H8AV0SQX4D) Sodium Stearyl Fumarate (UNII: 7CV7WJK4UI) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (blue band) Score no score Shape OVAL Size 23mm Flavor Imprint Code ZEG Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82632-100-01 1 in 1 CARTON 03/01/2024 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:82632-100-03 1 in 1 CARTON 03/01/2024 2 42 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022281 03/01/2024 Labeler - Riley Consumer Care LLC (118598784)