INACTIVE INGREDIENT SECTION.

Inactive ingredients. ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate.

DOSAGE & ADMINISTRATION SECTION.

Directions. oadults 18 years of age and olderothis product is to be used once day (every 24 hours), every day for 14 daysoit may take to days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatmentotake tablet before eating in the morningodo not crush or chew tabletsoplace the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.otake every day for 14 daysodo not take more than tablet dayodo not use for more than 14 days unless directed by your doctorodo not take this medicine with alcoholRepeated 14-Day Course (if needed)oyou may repeat 14-day course every monthsodo not take for more than 14 days or more often than every months unless directed by doctorochildren under 18 years of age: ask doctor before use. Heartburn in children may sometimes be caused by serious condition.. oadults 18 years of age and older. othis product is to be used once day (every 24 hours), every day for 14 days. oit may take to days for full effect, although some people get complete relief of symptoms within 24 hours. otake tablet before eating in the morning. odo not crush or chew tablets. oplace the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.. otake every day for 14 days. odo not take more than tablet day. odo not use for more than 14 days unless directed by your doctor. odo not take this medicine with alcohol. oyou may repeat 14-day course every months. odo not take for more than 14 days or more often than every months unless directed by doctor. ochildren under 18 years of age: ask doctor before use. Heartburn in children may sometimes be caused by serious condition.

INDICATIONS & USAGE SECTION.

Use. otreats frequent heartburn (occurs or more days week)onot intended for immediate relief of heartburn; this drug may take to days for full effect. otreats frequent heartburn (occurs or more days week). onot intended for immediate relief of heartburn; this drug may take to days for full effect.

OTHER SAFETY INFORMATION.

Other information. oread the directions, warnings and package insert before useokeep the carton and package insert. They contain important information.ostore at 20-25C (68-77F)okeep product out of high heat and humidityoprotect product from moisture. oread the directions, warnings and package insert before use. okeep the carton and package insert. They contain important information.. ostore at 20-25C (68-77F). okeep product out of high heat and humidity. oprotect product from moisture.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient (in each tablet). Lansoprazole 15mg.

OTC - ASK DOCTOR SECTION.

Ask doctor before use if you have. oliver diseaseohad heartburn over months. This may be sign of more serious condition.oheartburn with lightheadedness, sweating or dizzinessochest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednessofrequent chest painofrequent wheezing, particularly with heartburnounexplained weight lossonausea or vomitingostomach pain. oliver disease. ohad heartburn over months. This may be sign of more serious condition.. oheartburn with lightheadedness, sweating or dizziness. ochest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness. ofrequent chest pain. ofrequent wheezing, particularly with heartburn. ounexplained weight loss. onausea or vomiting. ostomach pain.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if you are taking. owarfarin (blood-thinning medicine)oprescription antifungal or anti-yeast medicinesodigoxin (heart medicine)otheophylline (asthma medicine)otacrolimus or mycophenolate mofetil (immune system medicines)oatazanavir (medicine for HIV infection)omethotrexate (arthritis medicine). owarfarin (blood-thinning medicine). oprescription antifungal or anti-yeast medicines. odigoxin (heart medicine). otheophylline (asthma medicine). otacrolimus or mycophenolate mofetil (immune system medicines). oatazanavir (medicine for HIV infection). omethotrexate (arthritis medicine).

OTC - DO NOT USE SECTION.

Do not use. oif you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of serious condition. See your doctor.. oif you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of serious condition. See your doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breast-feeding,. ask health professional before use.

OTC - PURPOSE SECTION.

Purpose. Acid reducer.

OTC - QUESTIONS SECTION.

Questions or comments. 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST. Consumer Information Treats Frequent HeartburnLansoprazoleDelayed ReleaseOrally Disintegrating Tablets 15 mgacid reducero May take to days for full effectPlease read the entire package insert before taking Lansoprazole Delayed Release Orally Disintegrating Tablets.Save for future reference.How Lansoprazole delayed release orally disintegrating tablets Treats Your Frequent HeartburnLansoprazole delayed release orally disintegrating tablets stops acid production at the source the pumps that release acid into the stomach. Lansoprazole delayed release orally disintegrating tablet is taken once day (every 24 hours), every day for 14 days.What You Can Expect When Taking Lansoprazole delayed release orally disintegrating tabletsFrequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole delayed release orally disintegrating tablets in the morning before eating. Lansoprazole is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take to days for full effect. Make sure you take Lansoprazole delayed release orally disintegrating tablets every day for 14 days to treat your frequent heartburn.Who Should Take Lansoprazole delayed release orally disintegrating tabletsAdults (18 years and older) with frequent heartburn when you have heartburn or more days week.Who Should NOT Take Lansoprazole delayed release orally disintegrating tabletsPeople who have one episode of heartburn week or less, or who want immediate relief of heartburn.How to Take Lansoprazole delayed release orally disintegrating tablets 14-DAY Course of TreatmentoTake tablet before eating in the morning.oDo not crush or chew tablets.oPlace the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.oTake every day for 14 days.oDo not take more than tablet day.oDo not use for more than 14 days unless directed by your doctor.oDo not take this medicine with alcohol.When to Take Lansoprazole delayed release orally disintegrating tablets AgainYou may repeat 14-day course of therapy every months.When to Talk to Your DoctorDo not take for more than 14 days or more often than every months unless directed by doctor.Warnings and When to Ask Your DoctorAllergy alert: Do not use if you are allergic to lansoprazoleDo not useoif you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of serious condition. See your doctor.Ask doctor before use if you haveoliver diseaseohad heartburn over months. This may be sign of more serious condition.oheartburn with lightheadedness, sweating or dizzinessochest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednessofrequent chest painofrequent wheezing, particularly with heartburnounexplained weight lossonausea or vomitingostomach painAsk doctor or pharmacist before use if you are takingowarfarin (blood-thinning medicine)oprescription antifungal or anti-yeast medicinesodigoxin (heart medicine)otheophylline (asthma medicine)otacrolimus or mycophenolate mofetil (immune system medicines)oatazanavir (medicine for HIV infection)omethotrexate (arthritis medicine)Stop use and ask doctor ifoyour heartburn continues or worsensoyou need to take this product for more than 14 daysoyou need to take more than course of treatment every monthsoyou get diarrheaoyou develop rash or joint painIf pregnant or breast-feeding, ask health care professional before use.Keep out of reach of children.In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).Tips for Managing HeartburnoAvoid 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.oEat slowly and do not eat big meals.oDo not eat late at night or just before bedtime.oDo not lie flat or bend over soon after eating.oRaise the head of your bed.oWear loose-fitting clothing around your stomach.oIf you are overweight, lose weight.oIf you smoke, quit smoking.Clinical studies prove that lansoprazole effectively treats frequent heartburnIn three clinical studies, lansoprazole was shown to be significantly better than placebo in treating frequent heartburn.How Lansoprazole delayed release orally disintegrating tablets is SoldThis medicine is available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat 14-day course every months.For Questions or Comments About Lansoprazole delayed release orally disintegrating tabletsCall 1-800-719-9260weekdays 7:30 AM to 5:00 PM ESTMade in IsraelManufactured by:Dexcel Pharma Technologies Ltd.10 Hakidma Street, Yokneam 2069200, Israel:8U100 00 J21249460078-AOR:8U174 00 J2. oTake tablet before eating in the morning.. oDo not crush or chew tablets.. oPlace the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.. oTake every day for 14 days.. oDo not take more than tablet day.. oDo not use for more than 14 days unless directed by your doctor.. oDo not take this medicine with alcohol.. oif you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of serious condition. See your doctor.. oliver disease. ohad heartburn over months. This may be sign of more serious condition.. oheartburn with lightheadedness, sweating or dizziness. ochest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness. ofrequent chest pain. ofrequent wheezing, particularly with heartburn. ounexplained weight loss. onausea or vomiting. ostomach pain. owarfarin (blood-thinning medicine). oprescription antifungal or anti-yeast medicines. odigoxin (heart medicine). otheophylline (asthma medicine). otacrolimus or mycophenolate mofetil (immune system medicines). oatazanavir (medicine for HIV infection). omethotrexate (arthritis medicine). oyour heartburn continues or worsens. oyou need to take this product for more than 14 days. oyou need to take more than course of treatment every months. oyou get diarrhea. oyou develop rash or joint pain. oAvoid 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.. oEat slowly and do not eat big meals.. oDo not eat late at night or just before bedtime.. oDo not lie flat or bend over soon after eating.. oRaise the head of your bed.. oWear loose-fitting clothing around your stomach.. oIf you are overweight, lose weight.. oIf you smoke, quit smoking.

OTC - STOP USE SECTION.

Stop use and ask doctor if. oyour heartburn continues or worsensoyou need to take this product for more than 14 daysoyou need to take more than course of treatment every monthsoyou get diarrheaoyou develop rash or joint pain. oyour heartburn continues or worsens. oyou need to take this product for more than 14 days. oyou need to take more than course of treatment every months. oyou get diarrhea. oyou develop rash or joint pain. If pregnant or breast-feeding,. ask health professional before use.. Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package/Label Principal Display Panel MELTech(TM)Melts In Your MouthTreats Frequent HeartburnCompare to Prevacid(R) 24 HR active ingredientLansoprazoleDELAYED RELEASE ORALLY DISINTEGRATING TABLETS 15 mg ACID REDUCERMELTS IN YOUR MOUTH; DISSOLVES WITHOUT WATERORALLY DISINTEGRATING TABLETS24 HOURMay take to days for full effectACTUAL SIZE42 TABLETSTHREE 14-DAY COURSES OF TREATMENTSTRAWBERRY FLAVOR. Lansoprazole Carton Image 1. Lansoprazole Carton Image 2.

SPL UNCLASSIFIED SECTION.

Consumer Information Treats Frequent HeartburnLansoprazoleDelayed ReleaseOrally Disintegrating Tablets 15 mgacid reducero May take to days for full effectPlease read the entire package insert before taking Lansoprazole Delayed Release Orally Disintegrating Tablets.Save for future reference.How Lansoprazole delayed release orally disintegrating tablets Treats Your Frequent HeartburnLansoprazole delayed release orally disintegrating tablets stops acid production at the source the pumps that release acid into the stomach. Lansoprazole delayed release orally disintegrating tablet is taken once day (every 24 hours), every day for 14 days.What You Can Expect When Taking Lansoprazole delayed release orally disintegrating tabletsFrequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole delayed release orally disintegrating tablets in the morning before eating. Lansoprazole is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take to days for full effect. Make sure you take Lansoprazole delayed release orally disintegrating tablets every day for 14 days to treat your frequent heartburn.Who Should Take Lansoprazole delayed release orally disintegrating tabletsAdults (18 years and older) with frequent heartburn when you have heartburn or more days week.Who Should NOT Take Lansoprazole delayed release orally disintegrating tabletsPeople who have one episode of heartburn week or less, or who want immediate relief of heartburn.How to Take Lansoprazole delayed release orally disintegrating tablets 14-DAY Course of TreatmentoTake tablet before eating in the morning.oDo not crush or chew tablets.oPlace the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.oTake every day for 14 days.oDo not take more than tablet day.oDo not use for more than 14 days unless directed by your doctor.oDo not take this medicine with alcohol.When to Take Lansoprazole delayed release orally disintegrating tablets AgainYou may repeat 14-day course of therapy every months.When to Talk to Your DoctorDo not take for more than 14 days or more often than every months unless directed by doctor.Warnings and When to Ask Your DoctorAllergy alert: Do not use if you are allergic to lansoprazoleDo not useoif you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of serious condition. See your doctor.Ask doctor before use if you haveoliver diseaseohad heartburn over months. This may be sign of more serious condition.oheartburn with lightheadedness, sweating or dizzinessochest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednessofrequent chest painofrequent wheezing, particularly with heartburnounexplained weight lossonausea or vomitingostomach painAsk doctor or pharmacist before use if you are takingowarfarin (blood-thinning medicine)oprescription antifungal or anti-yeast medicinesodigoxin (heart medicine)otheophylline (asthma medicine)otacrolimus or mycophenolate mofetil (immune system medicines)oatazanavir (medicine for HIV infection)omethotrexate (arthritis medicine)Stop use and ask doctor ifoyour heartburn continues or worsensoyou need to take this product for more than 14 daysoyou need to take more than course of treatment every monthsoyou get diarrheaoyou develop rash or joint painIf pregnant or breast-feeding, ask health care professional before use.Keep out of reach of children.In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).Tips for Managing HeartburnoAvoid 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.oEat slowly and do not eat big meals.oDo not eat late at night or just before bedtime.oDo not lie flat or bend over soon after eating.oRaise the head of your bed.oWear loose-fitting clothing around your stomach.oIf you are overweight, lose weight.oIf you smoke, quit smoking.Clinical studies prove that lansoprazole effectively treats frequent heartburnIn three clinical studies, lansoprazole was shown to be significantly better than placebo in treating frequent heartburn.How Lansoprazole delayed release orally disintegrating tablets is SoldThis medicine is available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat 14-day course every months.For Questions or Comments About Lansoprazole delayed release orally disintegrating tabletsCall 1-800-719-9260weekdays 7:30 AM to 5:00 PM ESTMade in IsraelManufactured by:Dexcel Pharma Technologies Ltd.10 Hakidma Street, Yokneam 2069200, Israel:8U100 00 J21249460078-AOR:8U174 00 J2. oTake tablet before eating in the morning.. oDo not crush or chew tablets.. oPlace the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.. oTake every day for 14 days.. oDo not take more than tablet day.. oDo not use for more than 14 days unless directed by your doctor.. oDo not take this medicine with alcohol.. oif you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of serious condition. See your doctor.. oliver disease. ohad heartburn over months. This may be sign of more serious condition.. oheartburn with lightheadedness, sweating or dizziness. ochest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness. ofrequent chest pain. ofrequent wheezing, particularly with heartburn. ounexplained weight loss. onausea or vomiting. ostomach pain. owarfarin (blood-thinning medicine). oprescription antifungal or anti-yeast medicines. odigoxin (heart medicine). otheophylline (asthma medicine). otacrolimus or mycophenolate mofetil (immune system medicines). oatazanavir (medicine for HIV infection). omethotrexate (arthritis medicine). oyour heartburn continues or worsens. oyou need to take this product for more than 14 days. oyou need to take more than course of treatment every months. oyou get diarrhea. oyou develop rash or joint pain. oAvoid 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.. oEat slowly and do not eat big meals.. oDo not eat late at night or just before bedtime.. oDo not lie flat or bend over soon after eating.. oRaise the head of your bed.. oWear loose-fitting clothing around your stomach.. oIf you are overweight, lose weight.. oIf you smoke, quit smoking.

WARNINGS SECTION.

Warnings. Allergy alert:do not use if you are allergic to lansoprazole.