Label: TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet

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

Drug Label Information

Updated October 16, 2015

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  • DESCRIPTION

    Each capsule contains:

    Tramadol Hydrochloride, USP ..........50 mg

  • DESCRIPTION

    Usual Dosage:  For dosage and other prescribing

    information, see accompanying insert.

  • STORAGE AND HANDLING

    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]

    Dispense in a tight container as defined in

    the USP.

    Keep out of reach of children.

  • DESCRIPTION

    DESCRIPTION

    Tramadol hydrochloride tablets, USP are a centrally acting analgesic.

  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY

    PHARMACODYNAMICS    Tramadol Hydrochloride contains tramadol, a centrally acting synthetic opoid

    analgesic.

  • CLINICAL STUDIES

    CLINICAL STUDIES

    Tramadol hydrochloride has been given in single oral doses pf 50, 75 and 100 mg to patients with pain

    following surgical procedures and pain following oral surgery (extraction if impacted molars).

  • INDICATIONS & USAGE

    INDICATIONS AND USAGE

    Tramadol hydrochloride tablets, USP are indicated for the management of moderate to

    moderately severe pain in adults.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS

    Tramadol hydrochloride tablets, USP should not be administered to patients who have previously

    demonstrated hypersensitivity to tramadol, any other component of this product or opoids.

  • WARNINGS

    WARNINGS

    Seizure Risk   Seizures have been reported in patients receiving Tramadol hydrochloride within the

    recommended dosage range.

  • PRECAUTIONS

    PRECAUTIONS

    Acute Abdominal Conditions   The administration of tramadol hydrochloride may complicate the clinical assessment

    of patients with acute abdominal conditions

  • ADVERSE REACTIONS

    ADVERSE REACTIONS

    Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label

    extension periods in U.S. clinical studies of chronic nonmalignant pain.

  • DRUG ABUSE AND DEPENDENCE

    DRUG ABUSE AND DEPENDENCE.

    Abuse   Tramadol has mu-opoid agonist activity.

  • OVERDOSAGE

    OVERDOSAGE

    Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to

    stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures,

    bradycardia, hypotension, cardiac arrest, and death.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION

    Adults (17 years of age and older)    For patients with moderate to moderately severe chronic pain not

    requiringrapid onset of analgesic effect, the tolerability of tramadol hydrochloride, USP can be improved by

    initiating therapy with a titration regimen:

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    TRAMADOL HYDROCHLORIDE  
    tramadol hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69512-627
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE50 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code AN;627
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69512-627-10100 in 1 BOTTLE
    150 mg in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07600310/01/2015
    Labeler - Alivio Medical Products, LLC (079670828)
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