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| Product NDC Code | 64239-112 | ||||||||||||||||||
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| Drug Name | Esomeprazole |
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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, ORALLY DISINTEGRATING, DELAYED RELEASE | ||||||||||||||||||
| RxCUI drug identifier | 2679449 | ||||||||||||||||||
| Application Number | NDA214278 | ||||||||||||||||||
| Labeler Name | Dexcel Pharma Technologies Ltd | ||||||||||||||||||
| 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.Drug Facts Active ingredient (in each tablet) Esomeprazole 20 mg (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate)
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.14-Day Course of Treatment take 1 tablet before eating in the morning do not crush or chew tablets place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water. 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 do not take this medicine with alcohol 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 before use. 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 acetone, alcohol, amino methacrylate copolymer, ascorbic acid, benzyl alcohol, cetyl alcohol, colloidal silicon dioxide, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, flavor, hypromellose, hypromellose phthalate, isopropyl alcohol, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, pregelatinized starch, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triacetin, triethyl citrate
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.Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 14-Day Course of Treatment take 1 tablet before eating in the morning do not crush or chew tablets place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water. 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 do not take this medicine with alcohol 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 before use. Heartburn in children may sometimes be caused by a serious condition.
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.Esomeprazole Esomeprazole Esomeprazole ESOMEPRAZOLE ACETONE ALCOHOL DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER ASCORBIC ACID BENZYL ALCOHOL CETYL ALCOHOL CROSPOVIDONE FD&C BLUE NO. 1--ALUMINUM LAKE FD&C BLUE NO. 2--ALUMINUM LAKE HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) ISOPROPYL ALCOHOL MANNITOL MICROCRYSTALLINE CELLULOSE MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) POLYSORBATE 80 SILICON DIOXIDE SODIUM STEARATE SODIUM STEARYL FUMARATE SORBITOL STARCH, CORN SUCRALOSE SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 20 Wildberry
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.NDC 64239-112-02 MELTech TM Melts in Your Mouth Compare to the active ingredient in Nexium® 24HR* Treats Frequent Heartburn! 24HR Esomeprazole Delayed Release Orally Disintegrating Tablets 20 mg Acid Reducer Melts in your mouth Dissolves without water 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect Wildberry Flavor Actual size image description
NDC 64239-112-03 MELTech TM Melts in Your Mouth Compare to the active ingredient in Nexium® 24HR* Treats Frequent Heartburn! 24HR Esomeprazole Delayed Release Orally Disintegrating Tablets 20 mg Acid Reducer Melts in your mouth Dissolves without water 28 TABLETS Two 14-day courses of treatment May take 1 to 4 days for full effect Wildberry Flavor Actual size image description
NDC 64239-112-04 MELTech TM Melts in Your Mouth Compare to the active ingredient in Nexium® 24HR* Treats Frequent Heartburn! 24HR Esomeprazole Delayed Release Orally Disintegrating Tablets 20 mg Acid Reducer Melts in your mouth Dissolves without water 42 TABLETS Three 14-day courses of treatment May take 1 to 4 days for full effect Wildberry Flavor Actual size image description
NDC 64239-112-05 MELTech TM Melts in Your Mouth FREE SAMPLE Compare to the active ingredient in Nexium® 24HR* Treats Frequent Heartburn! 24HR Esomeprazole Delayed Release Orally Disintegrating Tablets 20 mg Acid Reducer Melts in your mouth Dissolves without water 2 TABLETS First 2 doses of a 14-day course of treatment May take 1 to 4 days for full effect Wildberry Flavor Actual size image description
NDC 64239-112-07 MELTech TM Melts in Your Mouth Compare to the active ingredient in Nexium® 24HR* Treats Frequent Heartburn! 24HR Esomeprazole Delayed Release Orally Disintegrating Tablets 20 mg Acid Reducer Melts in your mouth Dissolves without water 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect Wildberry Flavor Actual size image description
NDC 64239-112-08 MELTech TM Melts in Your Mouth Compare to the active ingredient in Nexium® 24HR* Treats Frequent Heartburn! 24HR Esomeprazole Delayed Release Orally Disintegrating Tablets 20 mg Acid Reducer Melts in your mouth Dissolves without water 28 TABLETS Two 14-day courses of treatment May take 1 to 4 days for full effect Wildberry Flavor Actual size image description
NDC 64239-112-09 MELTech TM Melts in Your Mouth Compare to the active ingredient in Nexium® 24HR* Treats Frequent Heartburn! 24HR Esomeprazole Delayed Release Orally Disintegrating Tablets 20 mg Acid Reducer Melts in your mouth Dissolves without water 42 TABLETS Three 14-day courses of treatment May take 1 to 4 days for full effect Wildberry Flavor Actual size image description
NDC 64239-112-10 MELTech TM Melts in Your Mouth FREE SAMPLE Compare to the active ingredient in Nexium® 24HR* Treats Frequent Heartburn! 24HR Esomeprazole Delayed Release Orally Disintegrating Tablets 20 mg Acid Reducer Melts in your mouth Dissolves without water 2 TABLETS First 2 doses of a 14-day course of treatment May take 1 to 4 days for full effect Wildberry Flavor Actual size image description
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.Tips for Managing Heartburn Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables. Eat slowly and do not eat big meals. Do not eat late at night or just before bedtime. Do not lie flat or bend over soon after eating. Raise the head of your bed. Wear loose-fitting clothing around your stomach. If you are overweight, lose weight. If you smoke, 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 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).
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 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).
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.Esomeprazole 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 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).
Esomeprazole: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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 before use. Heartburn in children may sometimes be caused by a serious condition.
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 (1-800-222-1222).
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 20-25°C (68-77°F); keep product out of high heat and moisture store in the original package
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? 1-800-XXX-XXXX: Weekdays XXX AM to XXX PM EST
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 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).
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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).
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 esomeprazole Esomeprazole 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 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).
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