Label: OMEPRAZOLE AND SODIUM BICARBONATE- omeprazole, sodium bicarbonate capsule, gelatin coated
- NDC Code(s): 59779-732-01, 59779-732-03
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated August 7, 2019
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- Active ingredients (in each capsule)
Omeprazole 20 mg
Sodium Bicarbonate 1100 mgClose
Allows absorption of this omeprazole productClose
- 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.
Allergy alert: Do not use if you are allergic to omeprazole
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.
Ask a doctor before use if you have
- had heartburn over 3 months. This may be a sign of a more serious condition.
- 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
- 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
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).
- 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 oC (68-77 oF)
- 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
- 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 dioxideClose
- Questions or comments?
- Package/Label Principal Display Panel
Compare to the active ingredients in Zegerid OTC®
Treats Frequent Heartburn
Omeprazole and Sodium Bicarbonate
Capsules, 20 mg/1100 mg
Allows absorption of this omeprazole product
Three 14-day courses of treatment
- INGREDIENTS AND APPEARANCE
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole, sodium bicarbonate capsule, gelatin coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-732 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 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (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 732 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-732-01 1 in 1 CARTON 07/15/2016 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59779-732-03 3 in 1 CARTON 07/15/2016 2 14 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 07/15/2016 Labeler - CVS Pharmacy (062312574)