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:

LITTLE PHARMA, INC.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acid reducer - 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
LITTLE PHARMA, INC.
----------
CURIST HEARTBURN RELIEF (ESOMEPRAZOLE)
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH CAPSULE)_
*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg
esomeprazole
magnesium trihydrate)
_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 DOCTOR ORPHARMACIST BEFORE USE IF YOU ARE
taking a prescription drug. Acid reducers may interact with certain
prescription
drugs.
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
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 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 o