Naproxen description, usages, side effects, indications, overdosage, supplying and lots more!

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Naproxen

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

WARNINGSWARNINGSWARNINGS

NAPROXEN DESCRIPTION



Naproxen








CLINICAL PHARMACOLOGY


PHARMACODYNAMICS




PHARMACOKINETICS






PRECAUTIONS: Nursing Mothers



WARNINGS: Renal Effects


DOSAGE AND ADMINISTRATION







WARNINGS: Renal Effects

CLINICAL STUDIES














INDICATIONS & USAGE

WARNINGS












NAPROXEN CONTRAINDICATIONS



WARNINGS: Anaphylactoid ReactionsPRECAUTIONS: Preexisting Asthma
WARNINGS

WARNINGS




Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
CONTRAINDICATIONS










WARNINGS: Advanced Renal Disease




CONTRAINDICATIONSPRECAUTIONS: Preexisting Asthma





PRECAUTIONS

General
Naproxen-containing products such as Naproxen Sodium Tablets, USP, and other naproxen products should not be used concomitantly since they all circulate in the plasma as the naproxen anion.





Hepatic Effects




Hematological Effects


Preexisting Asthma:




INFORMATION FOR PATIENTS



WARNINGS: Cardiovascular Effects
WARNINGS: Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation



WARNINGS



LABORATORY TESTS



DRUG INTERACTIONS










WARNINGS: Renal Effects










DRUG & OR LABORATORY TEST INTERACTIONS




CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY









LABOR & DELIVERY




NURSING MOTHERS



PEDIATRIC USE

DOSAGE AND ADMINISTRATIONDOSAGE AND ADMINISTRATION

GERIATRIC USE



WARNINGS
WARNINGS: Renal Effects

NAPROXEN ADVERSE REACTIONS


CLINICAL PHARMACOLOGY






































OVERDOSAGE





DOSAGE & ADMINISTRATION



















HOW SUPPLIED









INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
CROSCARMELLOSE SODIUM

MAGNESIUM STEARATE
POLYVINYL ALCOHOL
POVIDONE
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

















Naproxen



Naproxen

Naproxen

Naproxen TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-684(NDC:53746-188)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naproxen sodium NAPROXEN 250 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
povidone
talc
titanium dioxide
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
white 10 mm IP;188;250 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-684-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078432 2011-05-13


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Be sure to consult your doctor before taking any medication!
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