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Nexium 24HR by Wyeth Consumer Healthcare LLC

Medically reviewed on Jan 16, 2018

Dosage form: tablet
Ingredients: ESOMEPRAZOLE MAGNESIUM 20mg
Labeler: Wyeth Consumer Healthcare LLC
NDC Code: 0573-2451

Nexium® 24HR

Drug Facts

Active ingredient (in each tablet)

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

Purpose

Acid reducer

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 (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.

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)

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

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

NEXIUM 24HR 
esomeprazole magnesium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2451
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE (15 MPA.S AT 5%) 
D&C RED NO. 27 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
GLYCERYL MONOSTEARATE 
HYDROXYPROPYL CELLULOSE (1200000 MW) 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
MICA 
MICROCRYSTALLINE CELLULOSE 
PARAFFIN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
SODIUM STEARYL FUMARATE 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize14mm
FlavorImprint CodeN;20;mg
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-2451-141 BOTTLE in 1 CARTON
114 TABLET in 1 BOTTLE
2NDC:0573-2451-423 BOTTLE in 1 BLISTER PACK
214 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20792002/06/2016
Labeler - Wyeth Consumer Healthcare LLC (828831730)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-2451), LABEL(0573-2451), MANUFACTURE(0573-2451), PACK(0573-2451)
Establishment
NameAddressID/FEIOperations
Wyeth Consumer Healthcare LLC828831730ANALYSIS(0573-2451), MANUFACTURE(0573-2451)

 
Wyeth Consumer Healthcare LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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