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| Product NDC Code | 30142-992 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Omeprazole |
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| Type | Generic | ||||||
| Pharm Class | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, DELAYED RELEASE | ||||||
| RxCUI drug identifier | 402014 | ||||||
| Application Number | ANDA207891 | ||||||
| Labeler Name | THE KROGER COMPANY | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Omeprazole USP 20 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide. The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac. Questions or Comments Call toll free 1-800-818-4555 weekdays.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • 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
Purpose
Information about the drug product’s indications for use.Purpose Acid reducer
Spl product data elements
Usually a list of ingredients in a drug product.omeprazole omeprazole OMEPRAZOLE OMEPRAZOLE ANHYDROUS LACTOSE HYPROMELLOSE, UNSPECIFIED HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) FERRIC OXIDE RED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MONOETHANOLAMINE METHYLCELLULOSE (1500 MPA.S) PROPYLENE GLYCOL SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM STEARATE SODIUM STEARYL FUMARATE SODIUM LAURYL SULFATE TRIETHYL CITRATE TALC TITANIUM DIOXIDE AMMONIA FERROSOFERRIC OXIDE BUTYL ALCOHOL SHELLAC brownish pink bioconvex 20
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton COMPARE TO PRILOSEC OTC ® *See bottom panel NDC 30142-992-28 Kroger ® See new warning information Omeprazole Delayed-release Tablets 20 mg ACID REDUCER SWALLOW- DO NOT CHEW OUR PHARMACIST RECOMMENDED Treats FREQUENT Heartburn! 24 HR 28 TABLETS Two 14-Day Courses of Treatment May Take 1 to 4 Days for Full Effect actual size PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • read the directions and warnings before use • keep the carton. It contains important information. • store at 20 to 25° C (68 to 77° F) and protect from moisture
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments Call toll free 1-800-818-4555 weekdays.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. 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).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API