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NDC 57483-0740-42 omeprazole 20.6 mg/1 Details
omeprazole 20.6 mg/1
omeprazole is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by INNOVUS PHARMACEUTICALS, INC.. The primary component is OMEPRAZOLE MAGNESIUM.
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: 57483-0740-42Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Omeprazole
Product Information
| NDC | 57483-0740 |
|---|---|
| Product ID | 57483-740_ce5c9fdc-0c50-4315-8f11-e00c9810abd0 |
| 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 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | omeprazole |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 20.6 |
| Active Ingredient Units | mg/1 |
| Substance Name | OMEPRAZOLE MAGNESIUM |
| Labeler Name | INNOVUS PHARMACEUTICALS, INC. |
| Pharmaceutical Class | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210593 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 57483-0740-42 (57483074042)
| NDC Package Code | 57483-740-42 |
|---|---|
| Billing NDC | 57483074042 |
| Package | 3 BOTTLE in 1 CARTON (57483-740-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57483-740-01) |
| Marketing Start Date | 2020-08-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ce5c9fdc-0c50-4315-8f11-e00c9810abd0 Details
Active ingredient(in each capsule)
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, 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
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
If pregnant or breast-feeding, ask a health professional before use.
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).
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 capsule with a glass of water before eating in the morning
■ take every day for 14 days
■ do not take more than 1 capsule a day
■ do not use for more than 14 days unless directed by your doctor
■ swallow whole. Do not chew or crush capsules.
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.
Inactive Ingredients
FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| OMEPRAZOLE
omeprazole capsule, delayed release |
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| Labeler - INNOVUS PHARMACEUTICALS, INC. (962507187) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 184769029 | MANUFACTURE(57483-740) | |