OMEPRAZOLE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Reliable 1 Laboratories LLC

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 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE
RELIABLE 1 LABORATORIES LLC
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RELIABLE-1 OMEPRAZOLE 20 MG
_DRUG FACTS_
_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
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:
warfarin, clopidogrel or cilostazol (blood-thinning medicines)
prescription antifungal or anti-yeast medicines
diazepam (anxiety medicine)
digoxin (heart medicine)
tacrolimus or mycophenolate mofetil (immune system medicines)
prescription antiretrovirals (medicines for HIV infection)
methotrexate (arthritis medicine)
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 prodcut 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 g