FDA Label for Esomeprazole Magnesium
View Indications, Usage & Precautions
- DRUG FACTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE IF YOU HAVE:
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- INACTIVE INGREDIENTS
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 MG (14 CAPSULE CONTAINER LABEL)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 MG (14 CAPSULE CONTAINER CARTON)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 MG (28 CAPSULE CONTAINER CARTON)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 MG (42 CAPSULE CONTAINER CARTON)
Esomeprazole Magnesium Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each capsule)
*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate 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 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
- 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
- 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.
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20-25°C (68-77°F)
- Meets USP dissolution test 2
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
Other information
Inactive Ingredients
colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.
Questions or comments?
call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2018 Walgreen Co.
MADE IN INDIA
Package Label-Principal Display Panel - 20 Mg (14 Capsule Container Label)
Walgreens
MAY TAKE 1 TO 4 DAYS
FOR FULL EFFECT
NDC 0363-0508-05
Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg* / ACID REDUCER
CAPSULES 24 HOUR
•Treats frequent heartburn
14 CAPSULES
ONE 14-DAY COURSE OF TREATMENT
Package Label-Principal Display Panel - 20 Mg (14 Capsule Container Carton)
Walgreens
Compare to
Nexiumr® 24HR
active ingredient
NDC 0363-0508-05
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
ACID REDUCER
Esomeprazole
Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
CAPSULES 24 HOUR
•Treats frequent heartburn
14 CAPSULES
ONE 14-DAY COURSE OF TREATMENT
Package Label-Principal Display Panel - 20 Mg (28 Capsule Container Carton)
Walgreens
Compare to Nexium® 24HR
active ingredient
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
NDC 0363-0508-08
ACID REDUCER
Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
CAPSULES 24 HOUR
•Treats frequent heartburn
28 CAPSULES
TWO 14-DAY COURSE OF TREATMENT
Package Label-Principal Display Panel - 20 Mg (42 Capsule Container Carton)
Walgreens
Compare to Nexium® 24HR
active ingredient
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
NDC 0363-0508-10
ACID REDUCER
Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
CAPSULES 24 HOUR
•Treats frequent heartburn
42 CAPSULES
THREE 14-DAY COURSES OF TREATMENT
* Please review the disclaimer below.