NEXIUM 24HR- esomeprazole magnesium capsule, delayed release NEXIUM 24HR CLEARMINIS- esomeprazole magnesium capsule, delayed release

Nexium 24HR ClearMinis by

Drug Labeling and Warnings

Nexium 24HR ClearMinis by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each capsule)	Purpose
(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)
Esomeprazole 20 mg	Acid reducer

INDICATIONS & USAGE

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

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
• 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.

DOSAGE & ADMINISTRATION

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 capsule with a glass of water before eating in the morning
  • take every day for 14 days
  • do not take more than 1 capsule a day
  • swallow whole. Do not crush or chew capsules.
  • 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.

STORAGE AND HANDLING

Other Information

• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Nexium 24HR Capsules

corn starch, D&C red no. 28, FD&C blue no. 1, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

Nexium 24HR ClearMinis

carmine, corn starch, FD&C blue no. 2, FD&C blue no. 2 aluminum lake, FD&C red no. 3, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

QUESTIONS

Questions or comments?

call toll-free weekdays 9 AM to 5 PM EST at 1-866-226-1600

Made in France

For most recent product information, visit www.Nexium24HR.com

PRINCIPAL DISPLAY PANEL - 2 Capsule Blister Pack

Nexium®
24HR

1 esomeprazole magnesium
delayed-release capsule
20 mg/acid reducer
Marketed by: Pfizer
Madison, NJ 07940 USA

LOT/EXP

PEEL

SEPARATE

PRINCIPAL DISPLAY PANEL - 2 Capsule Blister Pack Carton

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

Capsules

2
CAPSULES
First 2 doses of a 14-day course
of treatment

May take 1 to 4 days for full effect

SAMPLE - NOT FOR SALE

PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

May take 1 to 4 days for full effect

14 Capsules
Capsules

One 14-day course of treatment

PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Carton

NDC: 0573-2450-14

See new warning

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

Capsules

14
CAPSULES

One 14-day course of treatment

May take 1 to 4 days for full effect

PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Blister Pack

NDC: 0573-2450-15

See new warning

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

May take 1 to 4 days
for full effect

14
CAPSULES

One 14-day course
of treatment

Capsules

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.

PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label - NCR

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

May take 1 to 4 days for full effect

14 Capsules
Capsules

One 14-day course of treatment

PRINCIPAL DISPLAY PANEL - 28 Capsule Bottle Carton

Arthritis Foundation
Ease of
Use℠
CAP

NDC: 0573-2450-28

See new warning
Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

Capsules

28
CAPSULES

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

Two 14-day courses of treatment

May take 1 to 4 days for full effect

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton

NDC: 0573-2450-42

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

Capsules

42
CAPSULES

Three 14-day courses of treatment

May take 1 to 4 days for full effect

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Blister Pack

NDC: 0573-2450-43

See new warning

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

May take 1 to 4 days for full effect

3 Pack

Capsules

42
CAPSULES

Three 14-day courses
of treatment

PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label - Clear Minis

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

May take 1 to 4 days for full effect

14 Capsules
Clear Minis™

One 14-day course of treatment

PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Carton - Clear Minis

NDC: 0573-2452-14

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

Clear Minis™

14
CAPSULES
One 14-day course of treatment

May take 1 to 4 days for full effect

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton - Clear Minis

NDC: 0573-2452-42

Treats Frequent Heartburn

Nexium®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

Clear Minis™

42
CAPSULES

Three 14-day courses of treatment

May take 1 to 4 days for full effect

INGREDIENTS AND APPEARANCE

NEXIUM 24HR 
esomeprazole magnesium capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2450
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	20 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	PURPLE (amethyst)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	NEXIUM;20;mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2450-14	1 in 1 CARTON	05/27/2014
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0573-2450-15	1 in 1 BLISTER PACK	05/27/2014
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0573-2450-28	2 in 1 CARTON	05/27/2014
3		14 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0573-2450-42	3 in 1 CARTON	05/27/2014
4		14 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0573-2450-43	3 in 1 BLISTER PACK	05/27/2014
5		14 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 0573-2450-44	3 in 1 CARTON	05/27/2014
6		14 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 0573-2450-56	2 in 1 PACKAGE	05/27/2014	07/31/2017
7		2 in 1 BLISTER PACK
7		14 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 0573-2450-17	1 in 1 CARTON	05/27/2014
8		14 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 0573-2450-02	1 in 1 CARTON	10/31/2014
9		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA204655	05/27/2014

NEXIUM 24HR CLEARMINIS 
esomeprazole magnesium capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2452
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	20 mg

Inactive Ingredients
Ingredient Name	Strength
CARMINIC ACID (UNII: CID8Z8N95N)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	PURPLE (amethyst) , YELLOW	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	NEXIUM;20;mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2452-14	1 in 1 CARTON	03/01/2017
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0573-2452-42	3 in 1 CARTON	03/01/2017
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0573-2452-43	3 in 1 BLISTER PACK	03/01/2017
3		14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA204655	03/01/2017

Labeler - Wyeth Consumer Healthcare LLC (828831730)