Label: CYCLOBENZAPRINE HYDROCHLORIDE tablet

  • NDC Code(s): 69512-541-10
  • Packager: Alivio Medical Products, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 15, 2015

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Each film-coated tablet contains:

    Cyclobenzaprine Hydrichloride, USP 10 mg

  • DESCRIPTION

    Usual Adult Dosage:

    See package outsert for dosage information

  • STORAGE AND HANDLING

    This container is not intended for household use.

    Dispense contents with a child-resistant closure

    (as required) and in tight, light-resistant container

    as defined in the USP.

    Store at 20 to 25 C (68 to 77 F); excursions

    permitted to 15 to 30 C (59 to 86 F) [See

    USP Controlled Room Temperature]. KEEP THIS

    AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

  • DESCRIPTION

    DESCRIPTION

    Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical

    formula C20H21N-HCl and a molecular weight of 311.9.

  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY

    Cyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle

    function. It is ineffective in muscle spasm due to central nervous system disease.

  • INDICATIONS & USAGE

    INDICATIONS AND USAGE

    Cyclobenzaprine hydrochloride tablets,USP are indicated as an adjunct to rest and physical therapy for

    relief of muscle spasm associated with acute, painful muscoskeletal conditions.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS

    Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase (MAO)

    inhibitors or within 14 days after their discontinuation.

  • WARNINGS

    WARNINGS

    Serotonin Syndrome. The development of a potentially life-threatening serotonin syndrome has been

    reported with Cyclobenzaprine hydrochloride when used in combination with other drugs, such as selective

    serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic

    antidepressants (TCAs), tramadol, bupropion, meperidine, verapimal,, or (MAO) inhibitors.

  • PRECAUTIONS

    PRECAUTIONS

    General. Because of its atropine - like action, cyclobenzaprine hydrochloride should be sued with caution

    in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure and

    in patients taking anticholinergic medication.

  • ADVERSE REACTIONS

    ADVERSE REACTIONS

    Incidence of most common adverse reactions in the 2 double-blind, placebo controlled - 5 mg studies

    (incidence of >3% on cyclobenzaprine hydrochloride 5 mg

  • DRUG ABUSE AND DEPENDENCE

    DRUG ABUSE AND DEPENDENCE

    Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be

    considered when cyclobenzaprine hydrochloride is administered, even though they have not been reported

    to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may

    produce nausea, headache and malaise. These are not indicative of addiction.

  • OVERDOSAGE

    OVERDOSAGE

    Although rare, deaths may occur from overdosage with cyclobenzaprine hydrochloride.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION

    For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets, USP is 5 mg three

    times a day.

  • HOW SUPPLIED

    HOW SUPPLIED

    Cyclobenzaprine hydrochloride tablets, USP 5 mg are supplied as butterscotch yellow-colored, capsule-

    shaped, film-coated convex tablets, debossed with "AN40" on one side and plain on the other side.

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    CYCLOBENZAPRINE HYDROCHLORIDE 
    cyclobenzaprine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69512-541
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE10 mg  in 10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Coloryellow (Yellow (Butterscotch)) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code AN41
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69512-541-10100 in 1 BOTTLE
    110 mg in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07821810/01/2015
    Labeler - Alivio Medical Products, LLC (079670828)