ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT)

Available from:

CHAIN DRUG MARKETING ASSOCIATION INC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acid reducer - treats frequent heartburn (occurs 2 or more days a week) 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 not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
CHAIN DRUG MARKETING ASSOCIATION INC
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH CAPSULE)
*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 20.7 mg esomeprazole
magnesium, USP)
PURPOS E
Acid reducer
US E(S )
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 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