Esomeprazole ESOMEPRAZOLE DEXCEL PHARMA TECHNOLOGIES LTD FDA Approved 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.

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each tablet) Esomeprazole 20 mg (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate)
Inactive Ingredients
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
Strengths
20 mg 22.3 mg
Quantities
14 tablets 28 tablets 42 tablets 2 tablets 2 dose
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
UNII
N3PA6559FT
Packaging

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

Package Descriptions
  • 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

Overview

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.

Indications & Usage

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.

Dosage & Administration

-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.

Warnings & Precautions
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).
Purpose

Purpose Acid reducer

Do Not Use

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).

When Using

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

Stop Use & Ask a Doctor

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).

Keep Out of Reach of Children

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).

Questions

Questions or comments? 1-800-XXX-XXXX: Weekdays XXX AM to XXX PM EST


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