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Family Wellness Esomeprazole Magnesium

Medically reviewed on October 9, 2017

Dosage form: capsule, delayed release
Ingredients: ESOMEPRAZOLE 20mg
Labeler: Family Dollar Services Inc
NDC Code: 55319-898

Family Dollar Services, Inc. Esomeprazole Magnesium Drug Facts

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)

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

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. (1-800-222-1222)

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

FD&C blue no. 1, FD&C red no. 3, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO NEXIUM® 24HR ACTIVE INGREDIENT

1 Bottle inside

Esomeprazole Magnesium

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

Delayed-Release Capsules, 20 mg

Acid Reducer

Treats Frequent Heartburn

24 HOUR

CAPSULES

One 14-day course of treatment

ACTUAL SIZE

14 Capsules

May take 1 to 4 days for full effect

FAMILY WELLNESS ESOMEPRAZOLE MAGNESIUM 
esomeprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-898
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE (ESOMEPRAZOLE) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 3 
FERRIC OXIDE RED 
GELATIN 
GLYCERYL MONOSTEARATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MEGLUMINE 
POLYSORBATE 80 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
POLYETHYLENE GLYCOLS 
SHELLAC 
Product Characteristics
ColorBLUE (opaque) Scoreno score
ShapeCAPSULE (oblong) Size14mm
FlavorImprint CodeL898
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-898-011 BOTTLE in 1 CARTON
114 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20719310/05/2017
Labeler - Family Dollar Services Inc (024472631)

 
Family Dollar Services Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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