NORTRIPTYLINE HYDROCHLORIDE solution

Nortriptyline Hydrochloride by

Drug Labeling and Warnings

Nortriptyline Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Store and Dispense

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

Preserve in tight, light-resistant containers as defined in the USP.

  • SPL UNCLASSIFIED SECTION

    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605
    www.paipharma.com

    R01/15

    I067802

  • Medication Guide

    Nortriptyline Hydrochloride Oral Solution USP
    (nor trip te len)

    Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

    Read the Medication Guide that comes with your or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about:

    What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

    1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
    2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
    3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
      • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
      • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
      • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

    Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

    Visual problems

    Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

    Who should not take nortriptyline hydrochloride?

    Do not take nortriptyline hydrochloride if you:

    What else do I need to know about antidepressant medicines?

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605
    www.paipharma.com

    MG0678400

    R01/15

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC: 0121-0678-16

    Nortriptyline
    Hydrochloride
    Oral Solution USP

    10 mg/5 mL
    base

    Each 5 mL contains:
    Nortriptyline hydrochloride
    equivalent to 10 mg of base.
    Alcohol 4%

    PHARMACIST: Provide one attached
    Medication Guide to each patient or caregiver
    at the time of dispensing.

    Rx ONLY

    16 fl oz (473 mL)

    pai
    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    NORTRIPTYLINE HYDROCHLORIDE 
    nortriptyline hydrochloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0121-0678
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NORTRIPTYLINE HYDROCHLORIDE (UNII: 00FN6IH15D) (NORTRIPTYLINE - UNII:BL03SY4LXB) NORTRIPTYLINE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0121-0678-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/23/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07560608/23/2000
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0678)

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