Nabumetone
REMEDYREPACK INC.
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
NABUMETONE DESCRIPTION
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
INDICATIONS & USAGE
NABUMETONE CONTRAINDICATIONS
WARNINGS
CARDIOVASCULAR EFFECTS
Gastrointestinal Effects: Risk of Ulceration, Bleeding and Perforation
PRECAUTIONS
INFORMATION FOR PATIENTS
LABORATORY TESTS
DRUG INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Impairment of Fertility
PREGNANCY
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
NABUMETONE ADVERSE REACTIONS
OVERDOSAGE
DOSAGE & ADMINISTRATION
HOW SUPPLIED
STORAGE AND HANDLING
SPL MEDGUIDE
MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)
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● with longer use of NSAID medicines
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● in people who have heart disease
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● can happen without warning symptoms
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● taking medicines calledcorticosteroidsandanticoagulants
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● at the lowest dose possible for your treatment
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● for the shortest time needed
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● different types of arthritis
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● menstrual cramps and other types of short-term pain
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● if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
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● for pain right before or after heart bypass surgery
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● about all of your medical conditions.
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● about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
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● if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
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● if you are breastfeeding. Talk to your doctor.
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● Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
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● Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Nabumetone
Nabumetone TABLET
Product Information
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Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:49349-301(NDC:49884-649) |
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
Ingredient Name
|
Basis of Strength
|
Strength
|
NABUMETONE NABUMETONE |
|
500 mg
|
Product Characteristics
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Color
|
Size
|
Imprint Code
|
Shape
|
yellow |
15 mm |
P649;500 |
OVAL |
Packaging
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
1 |
NDC:49349-301-02 |
30 in 1 BLISTER PACK |
|
|
Marketing Information
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
ANDA |
ANDA076009 |
2011-06-09 |
|
|
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!