NEXIUM 24HR- esomeprazole magnesium tablet

Nexium 24HR by

Drug Labeling and Warnings

Nexium 24HR 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 tablet)

Esomeprazole 20 mg (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate)

PURPOSE

Purpose

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 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.

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

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

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

Nexium is a registered trademark of AstraZeneca AB and is used under license.

PRINCIPAL DISPLAY PANEL - 14 Tablet Bottle Label

Treats Frequent Heartburn

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

May take 1 to 4 days for full effect

14 Tablets
Tablets

One 14-day course of treatment

PRINCIPAL DISPLAY PANEL - 14 Tablet Bottle Carton

NDC: 0573-2451-14

See new warning

Treats Frequent Heartburn

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

Tablets

May take 1 to 4 days for full effect

14
TABLETS

One 14-day course of treatment

PRINCIPAL DISPLAY PANEL - 42 Tablet Bottle Carton

See new warning
NDC: 0573-2451-42

Treats Frequent Heartburn

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

Tablets

May take 1 to 4 days for full effect

42
TABLETS

Three 14-day courses of treatment

INGREDIENTS AND APPEARANCE

NEXIUM 24HR 
esomeprazole magnesium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2451
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)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	PURPLE	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	N;20;mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2451-14	1 in 1 CARTON	02/06/2016
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0573-2451-42	3 in 1 BLISTER PACK	02/06/2016
2		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	NDA207920	02/06/2016

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
Wyeth Pharmaceuticals Company		829390975	ANALYSIS(0573-2451) , LABEL(0573-2451) , MANUFACTURE(0573-2451) , PACK(0573-2451)

Establishment
Name	Address	ID/FEI	Business Operations
Wyeth Consumer Healthcare LLC		828831730	ANALYSIS(0573-2451) , MANUFACTURE(0573-2451)