ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
29-10-2023

Aktiv ingrediens:

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

Tilgjengelig fra:

The Kroger Co.

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

                                ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
THE KROGER CO.
----------
DRUG FACTS
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
Esomeprazole may cause severe skin reactions. Symptoms may include:
skin reddening
blisters
rash
If an allergic reaction occurs, stop use and seek medical help right
away.
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
taking a prescription drug. Acid reducers may interact with certain
prescription
drugs.
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(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
                                
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