ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Disponible depuis:

Amneal Pharmaceuticals NY LLC

Mode d'administration:

ORAL

Type d'ordonnance:

OTC DRUG

indications thérapeutiques:

- 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

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
AMNEAL PHARMACEUTICALS NY LLC
----------
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, USP
20 MG/ACID REDUCER (OTC)
_DRUG FACTS_
_ACTIVE INGREDIENT_
_(IN EACH CAPSULE)_
_PURPOSE_
Esomeprazole 20 mg
Acid reducer
(*Each delayed-release capsule corresponds to 22.3 mg esomeprazole
magnesium
trihydrate)
_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 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 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 THE 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