Nexium 24HR description, usages, side effects, indications, overdosage, supplying and lots more!

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Nexium 24HR

Pfizer Consumer Healthcare

Nexium24HR


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

Uses

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 (immune system medicine)
  • 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 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.

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, 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

Questions or comments?

call toll-free 1-866-226-1600

Made in France

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

PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Label

Treats Frequent Heartburn

Nexium ®
24HR
(esomeprazole magnesium)
Delayed-Release Capsules
22.3 mg/Acid Reducer

May take 1 to 4 days for full effect

14 CAPSULES

One 14-day course of treatment

Nexium 24HR

PRINCIPAL DISPLAY PANEL - 14 Capsule Bottle Carton

NEW

Treats Frequent Heartburn

Nexium ®
24HR
(esomeprazole magnesium)
Delayed-Release Capsules
22.3 mg/Acid Reducer

14
CAPSULES

One 14-day course of treatment

May take 1 to 4 days for full effect

Nexium 24HR

Nexium 24HR

esomeprazole magnesium CAPSULE, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-2450
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE 22.3 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
ferric oxide red
GELATIN
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
polysorbate 80
SUCROSE
talc
titanium dioxide
TRIETHYL CITRATE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40

Product Characteristics

Color Size Imprint Code Shape
PURPLE (amethyst) 14 mm NEXIUM;20;mg CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 14 in 1 BOTTLE
2 14 in 1 BOTTLE
3 14 in 1 BOTTLE
4 14 in 1 BOTTLE
5 14 in 1 BOTTLE
6 NDC:0573-2450-43 3 in 1 BLISTER PACK

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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