Esomeprazole Magnesium: Package Insert and Label Information

ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release
Walgreens Company

BottleCarton

Active ingredient(s) in each capsule

*Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)

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 useif 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 lightheadness
  • 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 ant fungal or anti-yeast medicines
  • digoxin (heart medicine)
  • diazepam (anxiety medicine)
  • tacrolimus or mycophenolate mofetil (immune system medicine)
  • prescription antiretrovirals (medicines for HIV infection)
  • methotrexate (arthritis medicine)

Stop use and ask 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 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

  • each capsule contains: magnesium, 15 mg
  • read directions and warnings before use
  • keep the carton. It contains important information
  • store at 20 to 25°C (68 to 77°F)

Inactive ingredients

acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1, ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide

Questions or comments

call toll-free weekdays 9 AM to 7 PM EST at 1-888-375-3784

Tips for Managing Heartbun

  • 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.

Container Label

Container Label:

Bottle
(click image for full-size original)

Carton label

Carton
(click image for full-size original)

ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3298(NDC:43598-407)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Esomeprazole Magnesium (Esomeprazole) Esomeprazole 20 mg
Inactive Ingredients
Ingredient Name Strength
acetyltributyl citrate
Dibutyl Sebacate
Ferrosoferric Oxide
Gelatin
Glyceryl Monostearate
Hypromelloses
Magnesium Oxide
Magnesium Stearate
Methacrylic Acid — Ethyl Acrylate Copolymer (1:1) Type A
Poloxamer 188
Polysorbate 80
Povidone K30
Talc
Titanium Dioxide
PROPYLENE GLYCOL
Potassium Hydroxide
Shellac
Sucrose
Fd&C Blue No. 1
Product Characteristics
Color BLUE (light blue cap) , BLUE (dark blue body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code RDY;327
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-3298-14 1 BOTTLE in 1 CARTON contains a BOTTLE
1 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (0363-3298-14)
2 NDC:0363-3298-28 2 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (0363-3298-28)
3 NDC:0363-3298-42 3 BOTTLE in 1 CARTON contains a BOTTLE
3 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (0363-3298-42)
4 NDC:0363-3298-01 3 BOTTLE in 1 CARTON contains a BOTTLE
4 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (0363-3298-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207673 12/31/2018
Labeler — Walgreens Company (008965063)

Revised: 09/2019 Walgreens Company

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