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

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Cyclobenzaprine Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

CYCLOBENZAPRINE HYDROCHLORIDE DESCRIPTION


Cyclobenzaprine Hydrochloride






CLINICAL PHARMACOLOGY





Pharmacokinetics

PRECAUTIONS, Use in the ElderlyPRECAUTIONS, Impaired Hepatic Function

Elderly



Hepatic Impairment



Clinical Studies







Surveillance Program
ADVERSE REACTIONS

INDICATIONS & USAGE






CYCLOBENZAPRINE HYDROCHLORIDE CONTRAINDICATIONS






WARNINGS

WARNINGSADVERSE REACTIONS



PRECAUTIONS

General


Impaired Hepatic Function
CLINICAL PHARMACOLOGY, PharmacokineticsHepatic Impairment


INFORMATION FOR PATIENTS



DRUG INTERACTIONS

CONTRAINDICATIONS





CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY




NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE

CLINICAL PHARMACOLOGY, PharmacokineticsElderly

CYCLOBENZAPRINE HYDROCHLORIDE ADVERSE REACTIONS





Clinical Studies withSurveillance Program withCyclobenzaprine HCl Tablets 10 mgCyclobenzaprine HCl Tablets 10 mg












DRUG ABUSE AND DEPENDENCE



OVERDOSAGE




ADVERSE REACTIONS















DOSAGE & ADMINISTRATION

INDICATIONS AND USAGE
PRECAUTIONS, Impaired Hepatic FunctionUse in the Elderly

HOW SUPPLIED










PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Cyclobenzaprine Hydrochloride



Cyclobenzaprine Hydrochloride


Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-217(NDC:0591-3256)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
hydroxypropyl cellulose
HYPROMELLOSES
polyethylene glycol
MAGNESIUM STEARATE
cellulose, microcrystalline
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 8 mm WATSON;3256 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-217-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071611 2011-04-26


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