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NDC 41250-0938-03 omeprazole and sodium bicarbonate 20; 1100 mg/1; mg/1 Details
omeprazole and sodium bicarbonate 20; 1100 mg/1; mg/1
omeprazole and sodium bicarbonate is a ORAL CAPSULE, GELATIN COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is OMEPRAZOLE; SODIUM BICARBONATE.
MedlinePlus Drug Summary
Prescription omeprazole is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Related Packages: 41250-0938-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Omeprazole
Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic in certain conditions. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 41250-0938-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate
Product Information
| NDC | 41250-0938 |
|---|---|
| Product ID | 41250-938_a01d3c35-e6b0-43fa-b09d-cf0dd8e9280c |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | omeprazole and sodium bicarbonate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Omeprazole, sodium bicarbonate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, GELATIN COATED |
| Route | ORAL |
| Active Ingredient Strength | 20; 1100 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | OMEPRAZOLE; SODIUM BICARBONATE |
| Labeler Name | Meijer Distribution Inc |
| Pharmaceutical Class | Cytochrome P450 2C19 Inhibitors [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201361 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 41250-0938-03 (41250093803)
| NDC Package Code | 41250-938-03 |
|---|---|
| Billing NDC | 41250093803 |
| Package | 3 BOTTLE in 1 CARTON (41250-938-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE |
| Marketing Start Date | 2020-04-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bb7c1c5d-b915-42f5-a5a2-5f61b088028d Details
Use
Warnings
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
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- unexplained weight loss
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- nausea or vomiting
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- 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.
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
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- 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 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
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole, sodium bicarbonate capsule, gelatin coated |
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| Labeler - Meijer Distribution Inc (006959555) |