TOPCARE OMEPRAZOLE DELAYED RELEASE- 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:

Topco Associates LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acid reducer

Authorization status:

New Drug Application

Summary of Product characteristics

TOPCARE OMEPRAZOLE DELAYED RELEASE- OMEPRAZOLE TABLET, DELAYED
RELEASE
TOPCO ASSOCIATES LLC
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TOPCO ASSOCIATES LLC. OMEPRAZOLE DELAYED RELEASE TABLETS DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Omeprazole 20 mg
PURPOSE
Acid reducer
USE
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WARNINGS
ALLERGY ALERT: Do not use if you are allergic to omeprazole
DO NOT USE IF YOU HAVE:
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These may be signs of a serious condition. See your doctor.
ASK A DOCTOR BEFORE USE IF YOU HAVE:
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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:
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
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
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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
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14-DAY COURSE OF TREATMENT
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REPEATED 14-DAY COURSES (IF NEEDED)
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OTHER INFORMATION
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INACTIVE INGREDIENTS
benzyl alcohol, carmine, carnauba wax, FD&C blue #2/indigo carmine
aluminum lake,
flavor, hypromellose, hypromellose acetate succinate, lactose
monohydrate, menthol,
modified starch, monoethanolamine, polyethylene glycol 3350, sodium
lauryl sulfate,
sodium starch glycolate, sodium stearate, sodium stearyl fumarate,
sucralose, talc,
your heartburn continues or worsens
you need to take this pro