Label: FLEXERIL- cyclobenzaprine hcl 10mg tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 27, 2020

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

  • How Supplied Section

    HOW SUPPLIED

    Cyclobenzaprine Hydrochloride Tablets, USP are available containing 5 mg, 7.5 mg or 10 mg of cyclobenzaprine hydrochloride, USP.

    The 5 mg tablets are butter scotch yellow film-coated, round tablets debossed with 020 on one side and plain on other side. They are available as follows:

    NDC 52817-330-10

    bottles of 100 tablets

    NDC 52817-330-50

    bottles of 500 tablets

    The 7.5 mg tablets are white to off-white film-coated, round tablets debossed with 021 on one side and plain on other side. They are available as follows:

    NDC 52817-331-10

    bottles of 100 tablets

    The 10 mg tablets are orange-yellow film-coated, round tablets debossed with 022 on one side and plain on other side. They are available as follows:

    NDC 52817-332-10

    bottles of 100 tablets

    NDC 52817-332-00

    bottles of 1000 tablets

    NDC 52817-332-50

    bottles of 500 tablets

    Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]

    Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

    Distributed By:

    TruPharma, LLC

    Tampa,FL 33609

    Manufactured by:

    Rubicon Research Private Limited,

    Ambernath,Dist. Thane,421506 India

    Rev. 02, June 2018

  • Dosage and Administration Section

    DOSAGE AND ADMINISTRATION

    For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than 2 or 3 weeks is not recommended (see INDICATIONS AND USAGE).

    Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS: IMPAIRED HEPATIC FUNCTION, and Use in the Elderly).

  • Indications and Usage Section

    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 musculoskeletal conditions.

    Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.

    Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

    Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

  • Principal Display Panel

    Cyclobenzaprine 10mg

  • INGREDIENTS AND APPEARANCE
    FLEXERIL 
    cyclobenzaprine hcl 10mg tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0018(NDC:52817-332)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE10 mg
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 022
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0018-390 in 1 BOTTLE; Type 0: Not a Combination Product05/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20817005/31/2017
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0018)