OMEPRAZOLE MAGNESIUM capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (omeprazole - UNII:KG60484QX9)

Available from:

Chain Drug Marketing Association

INN (International Name):

OMEPRAZOLE MAGNESIUM

Composition:

omeprazole 20 mg

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

OMEPRAZOLE MAGNESIUM- OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
CHAIN DRUG MARKETING ASSOCIATION
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ACTIVE INGREDIENT (IN EACH CAPSULE)
*Omeprazole delayed-release capsules 20 mg
(equivalent to 20.6 mg omeprazole magnesium)
PURPOSE
Acid reducer
USE
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 omeprazole
Omeprazole 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 REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
for adults 18 years of age and older
this product is to be used once a day (every 24 hours), every day for
14 days
it may take 1 to 4 days for full effect; some people get complete
relief of symptoms
within 24 hours
14-DAY COURSE OF TREATMENT
swallow 1