omeprazole 20 mg/1
omeprazole · TABLET, DELAYED RELEASE · INNOVUS PHARMACEUTICALS, INC.
Omeprazole is an over-the-counter medication that reduces stomach acid and is used to treat heartburn, acid reflux, and related digestive conditions. It belongs to a class of drugs called proton pump inhibitors that work by decreasing the amount of acid your stomach produces.
Key Facts
- Brand Name
- omeprazole
- Generic Name
- omeprazole
- NDC Code (Product)
57483-840- Manufacturer
- INNOVUS PHARMACEUTICALS, INC.
- Strength
- 20 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- HUMAN OTC DRUG
- Application #
- ANDA207891
- Drug Class
- Cytochrome P450 2C19 Inhibitors [MoA]; Proton Pump Inhibitor [EPC]
- Marketing Start
- 08/10/2020
Recall History
Aidapak Services, LLC
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP: 5/29/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD73627_32, EXP: 5/30/2014.
Dr. Reddy's Laboratories, Inc.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
CutisPharma, Inc.
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Dr. Reddy's Laboratories, Inc.
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Breckenridge Pharmaceutical, Inc
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014.
Duren Health Mart Pharmacy
Lack of Processing Controls.
CutisPharma, Inc.
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Golden State Medical Supply Inc.
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use(s) 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; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush tablets 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.
Warnings
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 lightheadednes 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 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 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 o…
Frequently Asked Questions
What is omeprazole used for?
Omeprazole is an over-the-counter medication that reduces stomach acid and is used to treat heartburn, acid reflux, and related digestive conditions. It belongs to a class of drugs called proton pump inhibitors that work by decreasing the amount of acid your stomach produces.
Is omeprazole a controlled substance?
omeprazole is not classified as a controlled substance by the DEA.
What is the generic name for omeprazole?
The generic name for omeprazole is omeprazole. There are 12 other brand versions of omeprazole.
What is the NDC code for omeprazole 20 mg/1?
The NDC (National Drug Code) for omeprazole 20 mg/1 is 57483-840, listed by INNOVUS PHARMACEUTICALS, INC..
Other Omeprazole Brands
See all →- Acid Reducer20 mg/137835-189
- Omeprazole65628-070
- exchange select omeprazole20 mg/155301-915
- Omeprazole20 mg/160505-0065
- Omeprazole20 mg/155111-158
- good neighbor pharmacy omeprazole20 mg/146122-029
- Omeprazole20 mg/185509-1644
- Omeprazole Magnesium1 kg/kg55111-049
- Omeprazole and Sodium Bicarbonate20 mg/150228-363
- ZEGERID20 mg/168012-052
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)