NO COPY 1/16" (0.0625") IN FROM DIE (DASH LINE DOES NOT PRINT) PAA058427.FDA03 1/4" HINGE AREA UNVARNISHED (LINES DO NOT PRINT) BASE PANEL 3 090177e1874103d6\Final\Final On: 16-Nov-2015 22:09 d ay r e p d ART BLEEDS OFF 1/16" (0.0625") OUT FROM DIE (DASH LINE DOES NOT PRINT) t May take 1 to 4 days for full effect 2 TABLETS SAMPLE - NOT FOR SALE NO COPY 1/16" (0.0625") IN FROM DIE (DASH LINE DOES NOT PRINT) 0.125" X 0.125" DATA MATRIX CODE (ECC 200), PRINTED IN BLACK ON UNPRINTED WHITE BACKGROUND DATA MATRIX CODE = 058427 ART BLEEDS OFF 1/16" (0.0625") OUT FROM DIE (DASH LINE KISS CUT DOES NOT PRINT) (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 treatment every 4 months ■ you get diarrhea 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. 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 fu l effect 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 ■ swallow whole. Do not crush or chew tablets. ■ do not use for more than 14 days unless directed by your doctor 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. Other Information ■ read the directions and warnings before use ■ keep the carton. It contains important information. ■ store at 20-25°C (68-77°F) Questions or comments? call toll-free: weekdays 9 AM to 5 PM EST at 1-866-226-1600 NO COPY 1/16" (0.0625") IN FROM DIE (DASH LINE DOES NOT PRINT) TOP (BACK) PANEL 2 ® UNVARNISHED AND PRINTED IN BLACK FOR LOT & EXPIRATION AREA KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION. F Marketed by: Pfizer, Madison, NJ 07940 USA © 2015 Pfizer Inc. Made in France For most recent product information, visit www.Nexium24HR.com Treats Frequent Heartburn LI Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing. KISS CUT In For T H fo M E rm o R at re E io n TOP (FACE) PANEL 1 THIS LINE INDICATES DIE AND DOES NOT PRINT ART BLEEDS OFF 1/16" (0.0625") OUT FROM DIE (DASH LINE DOES NOT PRINT) 1/4" HINGE AREA UNVARNISHED (LINES DO NOT PRINT) Active ingredient (in each tablet) Purpose Esomeprazole 20 mg .................................................................................................................................................................Acid reducer (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate) 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 Warnings Allergy alert: Do not use if you are allergic to esomeprazole 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 ■ warfarin, clopidogrel or cilostazol (blood-thinning medicines) ■ prescription antifungal or anti-yeast medicines ■ digoxin (heart medicine) ■ diazepam (anxiety medicine) ■ tacrolimus or mycophenolate mofetil PRODUCTION Job Information (b) (4) THIS LINE INDICATES DIE AND DOES NOT PRINT (b) (4) THIS LINE INDICATES DIE AND DOES NOT PRINT (b) (4) (NOT COLOR ACCURATE) Color Legend (b) (4) DRUG FACTS TEXT DEFINED TYPE SIZE • HEADINGS 5.5 pt • SUBHEADINGS/BODY TEXT 5.5 pt • LEADING 5.5 pt • BULLETS 4.5 pt • SPACE BEFORE BULLET 2 ems • WARNING BOX LINE, HAIRLINES 1 pt, .5 pt Reference ID: 3851118 3848998 PRODUCTION Job Information • DRUG FACTS TITLE DRUG FACTS TEXT DEFINED 9 pt • DRUG FACTS CONTINUED 8 pt • HEADINGS 8 pt • SUBHEADINGS/BODY TEXT • LEADING • # OF CHARACTERS PER INCH • BULLETS • SPACE BEFORE BULLET 2 ems • BARLINES, HAIRLINES • SPACE BETWEEN HAIRLINES AND BOX END 1.5 pt, .5 pt 2 Color Legend First two doses of a 14-day course of treatment. TABLETS Treats Frequent Heartburn SAMPLE - NOT FOR SALE May take 1 to 4 days for full effect 2 spaces (NOT COLOR ACCURATE) (b) (4) 128 CODE = 056433 128 CODE AREA - SUBSET C 10 MIL DENSITY WITH 4 OR 6 DIGITS (CODE TO EXTEND TO EDGE OF FLAP - UNVARNISHED) PRINTED SIDE OF CARTON 128 CODE = 056433 128 CODE AREA esomeprazole delayed-release tablets 20 mg/acid reducer 128 CODE AREA Allergy alert: Do not use if you are allergic to esomeprazole 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. Warnings drug may take 1 to 4 days for full effect ■ not intended for immediate relief of heartburn; this a week) ■ treats frequent heartburn (occurs 2 or more days Uses Esomeprazole 20 mg ................................... Acid reducer (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate) Active ingredient (in each tablet) Purpose Drug Facts KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION. 128 CODE AREA PRINTED AREA FOR DATE & LOT LASER CODING (VARNISHED) 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 ■ warfarin, clopidogrel or cilostazol (blood-thinning medicines) ■ prescription antifungal or anti-yeast medicines ■ digoxin (heart medicine) ■ diazepam (anxiety 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 treatment every 4 months ■ you get diarrhea If pregnant or breast-feeding, ask a health professional before use. Drug Facts (continued) Do Not Use if seal under bottle cap imprinted with“SEALED for YOUR PROTECTION” is broken or missing. 128 CODE = 056433 Reference ID: 3851118 3848998 128 CODE AREA UNPRINTED AREA FOR DATE & LOT (UNVARNISHED) NO COLOR OR TEXT IN THIS AREA (UNVARNISHED) PAA056433.FDA03 Marketed by: Pfizer, Madison, NJ 07940 USA © 2015 Pfizer Inc. Made in France For most recent product information, visit www.Nexium24HR.com Nexium is a registered trademark of AstraZeneca AB and is used under license. 128 CODE = 056433 090177e18740fb70\Final\Final On: 16-Nov-2015 21:30 FOR LABEL POSITION ONLY DRUG FACTS LABEL LOCATION (UNVARNISHED) TYPE SIZE 6.5 pt 6 pt <39 5 pt (b) (4) FOLD LINE ADHESIVE AREA BASE PANEL Drug Facts (continued) PANEL #2 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. Other Information ■ read the directions and warnings before use ■ keep the carton. It contains important information. ■ store at 20-25°C (68-77°F) Tips for Managing Heartburn Drug Facts (continued) Inactive ingredients PANEL #4 PANEL #3 corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate Questions or comments? call toll-free: weekdays 9 AM to 5 PM at 1-866-226-1600 • 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. ■ adults 18 years of age and older ■ this product is to be used once a day (every 24 hours), every day for 14 days HE 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 ■ swallow whole. Do not crush or chew tablets. ■ do not use for more than 14 days unless directed by your doctor RE ■ may take 1 to 4 days for full effect LI 090177e18742b8e7\Final\Final On: 17-Nov-2015 14:44 Reference ID: 3851118 3848998 PRODUCTION Job Information LIFT/OPEN HERE AREA 3/16" X 3/16" DATA MATRIX CODE (ECC200), (b) (4) ON PRINTED IN UNPRINTED WHITE BACKGROUND DATA MATRIX CODE = 058218 Directions FT PANEL #1 NO COPY PERMITTED IN THIS AREA Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. NO COPY PERMITTED IN THIS AREA PAA058218.FDA03 Drug Facts (continued) (NOT COLOR ACCURATE) Color Legend (b) (4) DRUG FACTS TEXT DEFINED TYPE SIZE • DRUG FACTS TITLE N/A • DRUG FACTS CONTINUED 8 pt • HEADINGS 8 pt • SUBHEADINGS/BODY TEXT 6 pt • LEADING • # OF CHARACTERS PER INCH • BULLETS 6.5 pt <39 5 pt • SPACE BEFORE BULLET 2 ems • BARLINES, HAIRLINES 1.5 pt, .5 pt • SPACE BETWEEN HAIRLINES AND BOX END 2 spaces KISS CUT PAA069163.FDA01 ® e omeprazole UNVARNISHED AND PRINTED IN BLACK FOR LOT & EXPIRATION AREA KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION. ART BLEEDS OFF 1/16" (0.0625") OUT FROM DIE (DASH LINE DOES NOT PRINT) 20 0.125" X 0.125" DATA MATRIX CODE (ECC 200), PRINTED IN BLACK ON UNPRINTED WHITE BACKGROUND F May take 1 to 4 days for full effect 14 TABLETS One 14-day course of treatment LI Marketed by: Pfizer, Madison, NJ 07940 USA © 2015 Pfizer Inc. Made in France For most recent product information, visit www.Nexium24HR.com Treats Frequent Heartburn In For T H fo M E rm o R at re E io n TOP (FACE) PANEL 1 Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing. DATA MATRIX CODE = 069163 1/4" HINGE AREA UNVARNISHED (LINES DO NOT PRINT) 090177e1874103ef\Final\Final On: 16-Nov-2015 22:11 ART BLEEDS OFF 1/16" (0.0625") OUT FROM DIE (DASH LINE DOES NOT PRINT) (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 ake more than 1 course of treatment every 4 months ■ you get diarrhea 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. 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 ■ 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 ■ swallow whole. Do not crush or chew tablets. ■ do not use for more than 14 days unless directed by your doctor 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. Other Information ■ read the directions and warnings before use ■ keep the carton. It contains important information. ■ store at 20-25°C (68-77°F) Questions or comments? call toll-free: weekdays 9 AM to 5 PM EST at 1-866-226-1600 BASE PANEL 3 TOP (BACK) PANEL 2 KISS CUT THIS LINE INDICATES DIE AND DOES NOT PRINT (b) (4) NO COPY 1/16" (0.0625") IN FROM DIE (DASH LINE DOES NOT PRINT) Active ingredient (in each tablet) Purpose Esomeprazole 20 mg .................................................................................................................................................................Acid reducer (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate) 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 Warnings Allergy alert: Do not use if you are allergic to esomeprazole 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 ■ warfarin, clopidogrel or cilostazol (blood-thinning medicines) ■ prescription antifungal or anti-yeast medicines ■ digoxin (heart medicine) ■ diazepam (anxiety medicine) ■ tacrolimus or mycophenolate mofetil THIS LINE INDICATES DIE AND DOES NOT PRINT (b) (4) 1-1/16" (0.0625") CORNER RADIUS TYP PRODUCTION Job Information (b) (4) (NOT COLOR ACCURATE) Color Legend (b) (4) DRUG FACTS TEXT DEFINED TYPE SIZE • HEADINGS 5.5 pt • SUBHEADINGS/BODY TEXT 5.5 pt • LEADING 5.5 pt • BULLETS 4.5 pt • SPACE BEFORE BULLET 2 ems • WARNING BOX LINE, HAIRLINES 1 pt, .5 pt Reference ID: 3851118 3848998 UNCOATED NO COPY NO PRINT 128 Code: 069162 128 Code: 069162 128 Code: 069162 128 CODE AREA 128 C AR ODE EA E Clinically Proven to Treat Frequent Heartburn KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION. Drug Facts Active ingredient (in each tablet) Purpose Drug Facts (continued) Directions Uses ■ adults 18 years of age and older ■ treats frequent heartburn (occurs 2 or more days a week) ■ this product is to be used once a day (every 24 hours), ■ not intended for immediate relief of heartburn; this drug every day for 14 days may take 1 to 4 days for full effect 090177e187410630\Final\Final On: 16-Nov-2015 22:07 Warnings ■ may take 1 to 4 days for full effect Allergy alert: Do not use if you are allergic to esomeprazole 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 ■ warfarin, clopidogrel or cilostazol (blood-thinning medicines) ■ prescription antifungal or anti-yeast medicines ■ digoxin (heart medicine) ■ diazepam (anxiety 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 treatment every 4 months 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 ■ swallow whole. Do not crush or chew tablets. ■ do not use for more than 14 days unless directed by your doctor 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. Other Information ■ read the directions and warnings before use ■ keep the carton. It contains important information. ■ store at 20-25°C (68-77°F) INSIDE 1 BOTTLE 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. Treats Frequent Heartburn Treats Frequent Heartburn esomeprazole delayed-release tablets 20 mg/acid reducer esomeprazole delayed-release tablets 20 mg/acid reducer ® 14 TABLETS One 14-day course of treatment Inactive ingredients corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate Questions or comments? call toll-free: weekdays 9 AM to 5 PM EST at 1-866-226-1600 MICRO PRINT TABLETS ■ you get diarrhea If pregnant or breast-feeding, ask a health professional before use. Esomeprazole 20 mg......................................Acid reducer Keep out of reach of children. In case of overdose, get (Each delayed-release tablet corresponds to 22.3 mg medical help or contact a Poison Control Center right away. esomeprazole magnesium trihydrate) D CO 128 REA A Marketed by: Pfizer, Madison, NJ 07940 USA © 2015 Pfizer Inc. Made in France For most recent product information, visit www.Nexium24HR.com Nexium is a registered trademark of AstraZeneca AB and is used under license. 14 May take 1 to 4 days for full effect TABLETS ACTUAL SIZE TABLETS Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing. One 14-day course of treatment PAA069162.FDA01 FPO 128 CODE AREA 128 CODE AREA 3 0573 2451 14 128 CODE AREA 5 128 Code: 069162 128 CODE AREA - SUBSET C 10 MIL DENSITY WITH 4 OR 6 DIGITS (CODE TO EXTEND TO EDGE OF FLAP - UNVARNISHED) PRINTED SIDE OF CARTON 128 Code: 069162 MICRO PRINT 128 Code: 069162 LOT & EXP AREA. DARK COLOR FOR LASER PRINTING. 3/16" DATA MATRIX CODE WITH 1/8" QUIET ZONE ON ALL SIDES PRODUCTION Data Matrix: 069162 (b) (4) Job Information (NOT COLOR ACCURATE) Color Legend (b) (4) DRUG FACTS TEXT DEFINED • DRUG FACTS TITLE 9 pt • DRUG FACTS CONTINUED 8 pt • HEADINGS 8 pt • SUBHEADINGS/BODY TEXT • LEADING 6 pt 6.5 pt • # OF CHARACTERS PER INCH <39 • BULLETS 5 pt • SPACE BEFORE BULLET 2 ems • BARLINES, HAIRLINES 1.5 pt, .5 pt • SPACE BETWEEN HAIRLINES AND BOX END Reference ID: 3851118 3848998 TYPE SIZE 2 spaces (b) (4) UNCOATED NO COPY NO PRINT 128 CODE = 055397 128 CODE AREA 128 CODE = 055397 128 CODE = 055397 128 C AR ODE EA DE CO 8 12 REA A Clinically Proven to Treat Frequent Heartburn TABLETS KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION. Drug Facts Drug Facts (continued) Active ingredient (in each tablet) Purpose Esomeprazole 20 mg .....................................................................Acid reducer (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate) 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 090177e18742c569\Final\Final On: 17-Nov-2015 14:47 Warnings Allergy alert: Do not use if you are allergic to esomeprazole 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 ■ warfarin, clopidogrel or cilostazol (blood-thinning medicines) ■ prescription antifungal or anti-yeast medicines ■ digoxin (heart medicine) ■ diazepam (anxiety 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 treatment every 4 months ■ you get diarrhea Reference ID: 3851118 3848998 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. 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 ■ 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 ■ swallow whole. Do not crush or chew tablets. ■ do not use for more than 14 days unless directed by your doctor 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 ingredients corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate Questions or comments? call toll-free: weekdays 9 AM to 5 PM EST at 1-866-226-1600 INSIDE 2 BOTTLES 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. Treats Frequent Heartburn Treats Frequent Heartburn esomeprazole delayed-release tablets 20 mg/acid reducer Other Information ■ read the directions and warnings before use ■ keep the carton. It contains important information. ■ store at 20-25°C (68-77°F) MICRO PRINT LOCATION esomeprazole delayed-release tablets 20 mg/acid reducer Marketed by: Pfizer, Madison, NJ 07940 USA © 2015 Pfizer Inc. Made in France For most recent product information, visit www.Nexium24HR.com Nexium is a registered trademark of AstraZeneca AB and is used under license. 28 TABLETS ® r 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect ACTUAL SIZE TABLETS Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing. Two 14-day courses of treatment PAA055397.FDA03 PRODUCTION 128 CODE AREA FPO 128 CODE AREA 3 0573 2451 28 128 CODE AREA 2 (b) (4) DRUG FACTS TEXT DEFINED 9 pt • DRUG FACTS CONTINUED 8 pt • HEADINGS 8 pt • LEADING 128 CODE = 055397 128 CODE = 055397 LOT & EXP AREA. DARK COLOR FOR LASER PRINTING. 3/16" DATA MATRIX CODE WITH 1/8" QUIET ZONE ON ALL SIDES DATA MATRIX CODE = 055397 TYPE SIZE • DRUG FACTS TITLE • SUBHEADINGS/BODY TEXT MICRO PRINT LOCATION 128 CODE AREA - SUBSET C 10 MIL DENSITY WITH 4 OR 6 DIGITS (CODE TO EXTEND TO EDGE OF FLAP - UNVARNISHED) PRINTED SIDE OF CARTON 128 CODE = 055397 (NOT COLOR ACCURATE) 6 pt 6.5 pt • # OF CHARACTERS PER INCH <39 • BULLETS 5 pt • SPACE BEFORE BULLET 2 ems • BARLINES, HAIRLINES 1.5 pt, .5 pt • SPACE BETWEEN HAIRLINES AND BOX END 2 spaces (b) (4) UNCOATED NO COPY NO PRINT 128 CODE = 052733 128 CODE AREA 128 CODE = 052733 128 CODE = 052733 128 C AR ODE EA E D CO 128 REA A Clinically Proven to Treat Frequent Heartburn TABLETS KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION. Drug Facts Drug Facts (continued) Active ingredient (in each tablet) Purpose Esomeprazole 20 mg .....................................................................Acid reducer (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate) 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 090177e18741000e\Final\Final On: 16-Nov-2015 21:55 Warnings Allergy alert: Do not use if you are allergic to esomeprazole 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 ■ warfarin, clopidogrel or cilostazol (blood-thinning medicines) ■ prescription antifungal or anti-yeast medicines ■ digoxin (heart medicine) ■ diazepam (anxiety 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 treatment every 4 months ■ you get diarrhea Reference ID: 3851118 3848998 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. 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 ■ 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 ■ swallow whole. Do not crush or chew tablets. ■ do not use for more than 14 days unless directed by your doctor 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 ingredients corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate Questions or comments? call toll-free: weekdays 9 AM to 5 PM EST at 1-866-226-1600 INSIDE 3 BOTTLES 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. Treats Frequent Heartburn Treats Frequent Heartburn esomeprazole delayed-release tablets 20 mg/acid reducer Other Information ■ read the directions and warnings before use ■ keep the carton. It contains important information. ■ store at 20-25°C (68-77°F) MICRO PRINT LOCATION esomeprazole delayed-release tablets 20 mg/acid reducer Marketed by: Pfizer, Madison, NJ 07940 USA © 2015 Pfizer Inc. Made in France For most recent product information, visit www.Nexium24HR.com Nexium is a registered trademark of AstraZeneca AB and is used under license. 42 TABLETS ® 2 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect ACTUAL SIZE TABLETS Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing. Three 14-day courses of treatment PAA052733.FDA04 PRODUCTION 128 CODE AREA FPO 128 CODE AREA 3 0573 2451 42 128 CODE AREA 8 Color Legend DRUG FACTS TEXT DEFINED (b) (4) 9 pt • DRUG FACTS CONTINUED 8 pt • HEADINGS 8 pt • LEADING 128 CODE = 052733 128 CODE = 052733 LOT & EXP AREA. DARK COLOR FOR LASER PRINTING. 3/16" DATA MATRIX CODE WITH 1/8" QUIET ZONE ON ALL SIDES DATA MATRIX CODE = 052733 TYPE SIZE • DRUG FACTS TITLE • SUBHEADINGS/BODY TEXT MICRO PRINT LOCATION 128 CODE AREA - SUBSET C 10 MIL DENSITY WITH 4 OR 6 DIGITS (CODE TO EXTEND TO EDGE OF FLAP - UNVARNISHED) PRINTED SIDE OF CARTON 128 CODE = 052733 Job Information (NOT COLOR ACCURATE) 6 pt 6.5 pt • # OF CHARACTERS PER INCH <39 • BULLETS 5 pt • SPACE BEFORE BULLET 2 ems • BARLINES, HAIRLINES 1.5 pt, .5 pt • SPACE BETWEEN HAIRLINES AND BOX END 2 spaces 090177e18740ff37\Final\Final On: 16-Nov-2015 21:42 Color Legend (b) (4) • SPACE BETWEEN HAIRLINES AND BOX END 2 spaces • SPACE BEFORE BULLET 2 ems • BARLINES, HAIRLINES 1.5 pt, .5 pt • BULLETS • # OF CHARACTERS PER INCH • LEADING 6 pt <39 7.5 pt • DRUG FACTS TITLE 10 pt • DRUG FACTS CONTINUED 9 pt • HEADINGS 9 pt • SUBHEADINGS/BODY TEXT 7 pt DRUG FACTS TEXT DEFINED TYPE SIZE (NOT COLOR ACCURATE) Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing. Reference ID: 3851118 3848998 Job Information PRODUCTION s 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. (b) (4) esomeprazole delayed-release tablets 20 mg/acid reducer KEEP CARD FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION. Drug Facts Drug Facts (continued) Active ingredient (in each tablet) Purpose Esomeprazole 20 mg ....................................................... Acid reducer (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate) 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 Warnings Allergy alert: Do not use if you are allergic to esomeprazole 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. 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. 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 ■ 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 ■ swallow whole. Do not crush or chew tablets. ■ do not use for more than 14 days unless directed by your doctor 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. Other Information ■ read the directions and warnings before use ■ keep the card. It contains important information. ■ store at 20-25°C (68-77°F) ■ frequent wheezing, particularly with heartburn ■ unexplained weight loss ■ nausea or vomiting ■ stomach pain Inactive ingredients Ask a doctor or pharmacist before use if you are taking ■ warfarin, clopidogrel or cilostazol (blood-thinning medicines) ■ prescription antifungal or anti-yeast medicines ■ digoxin (heart medicine) ■ diazepam (anxiety medicine) ■ tacrolimus or mycophenolate mofetil (immune system medicines) ■ prescription antiretrovirals (medicines for HIV infection) ■ methotrexate (arthritis medicine) Stop use and ask a doctor if corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate Questions or comments? call toll-free: weekdays 9 AM to 5 PM EST at 1-866-226-1600 052736 ■ 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 Marketed by: Pfizer, Madison, NJ 07940 USA © 2015 Pfizer Inc. Made in France For most recent product information, visit www.Nexium24HR.com Nexium is a registered trademark of AstraZeneca AB and is used under license. FPO 3 DATA MATRIX CODE 0573 2451 43 WHITE HOLDOUT QUIET AREA LOT/EXP WHITE HOLDOUT REMOVE VARNISH REMOVE VARNISH IN THIS AREA ONLY 5 PAA052736.FDA04 Three 14-day courses of treatment TABLETS 42 3 Pack May take 1 to 4 days for full effect esomeprazole delayed-release tablets 20 mg/acid reducer Treats Frequent Heartburn