OMEPRAZOLE tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)

Available from:

Albertsons Companies

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- OMEPRAZOLE TABLET, DELAYED RELEASE
ALBERTSONS COMPANIES
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OMEPRAZOLE DELAYED RELEASE TABLETS
ACTIVE INGREDIENT(S)
Omeprazole USP, 20 mg
PURPOSE
Acid reducer
USE(S)
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 lightheadednes
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 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
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 tablet with a glass of water before eating in the morning
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