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:

Physicians Total Care, Inc.

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose 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:

New Drug Application

Summary of Product characteristics

OMEPRAZOLE - OMEPRAZOLE TABLET, DELAYED RELEASE
PHYSICIANS TOTAL CARE, INC.
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OMEPRAZOLE DELAYED RELEASE TABLETS, 20 MG
OMEPRAZOLE DELAYED RELEASE TABLETS, 20 MG DRUG FACTS
_ACTIVE INGREDIENT (IN EACH TABLET)_
Omeprazole delayed-release tablet, 20 mg
_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
_WARNING_
ALLERGY ALERT: Do not use if you are allergic to omeprazole
DO NOT USE if you have trouble or pain swallowing food, vomiting with
blood, or bloody or black
stools. 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.
heartburn with LIGHTHEADEDNESS, SWEATING OR DIZZINESS
chest pain or shoulder pain with shortness or breath; sweating; pain
spreading to arms, neck or
shoulders; or lightheadedness
frequent CHEST PAIN
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking
clopidogrel bisulfate (anti-blood clotting medicine)
warfarin (blood-thinning medicine)
prescription antifungal or anti-yeast medicines
diazepam (anxiety medicine)
digoxin (heart medicine)
tacrolimus (immune system medicine)
atazanavir (medicine for HIV infection)
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
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.
(1-800-2221222)
_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
it may take 1 to 4 days for full effect, although some people get
complete relief of symptoms within
24 hours
14-DAY COURSE OF T