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| Product NDC Code | 71713-201 | ||
|---|---|---|---|
| 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 | ANDA207740 | ||
| Labeler Name | Thirty Madison Inc | ||
| 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, 20mg
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 relief of symptoms within 24 hours • 14 day course of treatment •swallow 1 tablet with a glass of water befre 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 days 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 ammonia solution, ammonium hydroxide, carnauba wax, hypromellose acetate succinate, hypromellose, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, sodium stearate, sodium starch glycolate, shellac glaze, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanim dioxide, triethyl citrate, yellow iron oxide
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.Use • 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 AMMONIA CARNAUBA WAX HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) HYPROMELLOSES FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MONOETHANOLAMINE BUTYL ALCOHOL Polyethylene Glycol 3350 POLYVINYL ALCOHOL POVIDONE PROPYLENE GLYCOL FERRIC OXIDE RED SODIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO SHELLAC SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW brownish pink O20 Carton Bottle
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.Carton label
Bottle Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this 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 or comments? call 1-888-375-3784
Tips for Managing Heartburn • Do not lie flat or bend over after eating • Do not wear tight-fitting clothing around the stomach • Do not eat before bedtime • Raise the head of your bed • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables • Eat slowly and avoid big meals • If overweight, lose weight • Quit smoking
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or Pharmacist beofre using if you are taking: • warfarin, clopidogrel or cilostazol (blood thinning medications) • prescription antifungal or anti-yeast medicines • diazepam (anxiety medicine) • digoxin (heart medicine) • tacrolimus or mycophenolate mofetil (immune system medicines) • prescription antiretrovirals (medicines for HIV infection) • methotrexate (arthritis medicine)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
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 In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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 treatement every 4 months •you get diarrhea •you develop a rash or joint pain
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding ask a health professional before use.
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 SECTION 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 beofre using if you are taking: • warfarin, clopidogrel or cilostazol (blood thinning medications) • prescription antifungal or anti-yeast medicines • diazepam (anxiety medicine) • digoxin (heart medicine) • tacrolimus or mycophenolate mofetil (immune system medicines) • prescription antiretrovirals (medicines for HIV infection) • methotrexate (arthritis medicine) 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 treatement 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 (1800-222-1222)
Allergy alert Do not use if you are allergic to Omeprazole
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