ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG capsule, delayed release ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI 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:

MARKSANS PHARMA LIMITED

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 • 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. • 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 • taking a prescription drug. Acid reducers may interact with certain prescription drugs. • 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG -
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG CAPSULE,
DELAYED
RELEASE
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI - ESOMEPRAZOLE
MAGNESIUM DELAYED-RELEASE 20 MG MINI CAPSULE, DELAYED RELEASE
MARKSANS PHARMA LIMITED
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ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES USP 20 MG
ACTIVE INGREDIENT (IN EACH CAPSULE)
Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 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
• Esomeprazole may cause severe skin reactions. Symptoms include:
o skin reddening
o blisters
o rash
If an allergic reaction occurs, stop use and seek medical attention
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 REACH OF CHILDR