Label: ZEGERID OTC- omepraole, sodium bicarbonate capsule, gelatin coated
- NDC Code(s): 82632-699-01, 82632-699-03
- Packager: Riley Consumer Care LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 26, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each capsule)
- Purpose
- Use
-
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.
-
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.
-
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?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ZEGERID OTC
omepraole, sodium bicarbonate capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82632-699 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, BICARBONATE ION - UNII:HN1ZRA3Q20) 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 STEARYL FUMARATE (UNII: 7CV7WJK4UI) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (BLUE BAND) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82632-699-01 1 in 1 CARTON 01/10/2024 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:82632-699-03 1 in 1 CARTON 01/10/2024 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 ANDA ANDA201361 01/10/2024 Labeler - Riley Consumer Care LLC (118598784)
