Label: CHLORDIAZEPOXIDE- chlordiazepoxide capsule, gelatin coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 4, 2019

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

  • DESCRIPTION:
  • CLINICAL PHARMACOLOGY:
  • INDICATIONS AND USAGE:
  • CONTRAINDICATIONS:
  • WARNINGS:
  • PRECAUTIONS:
  • ADVERSE REACTIONS:
  • DRUG ABUSE AND DEPENDENCE:
  • OVERDOSAGE:
  • DOSAGE AND ADMINISTRATION:
  • STORAGE AND HANDLING
  • MEDICATION GUIDE

    Chlordiazepoxide Hydrochloride
    Capsules, USP C-IV

    What is the most important information I should know about chlordiazepoxide?


    Chlordiazepoxide is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.

    Chlordiazepoxide can make you sleepy or dizzy, and can slow your thinking and motor skills.

    o
    Do not drive, operate heavy machinery, or do other dangerous activities until you know how chlordiazepoxide affects you.
    o
    Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking chlordiazepoxide without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide may make your sleepiness or dizziness much worse.
    o
    Do not take more chlordiazepoxide than prescribed.

    What is chlordiazepoxide?


    Chlordiazepoxide is a prescription medicine used:
    o
    to treat anxiety disorders
    o
    for the short-term relief of the symptoms of anxiety
    o
    to treat withdrawal symptoms of acute alcoholism
    o
    preoperatively to treat apprehension and anxiety

    Chlordiazepoxide is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep chlordiazepoxide in a safe place to prevent misuse and abuse. Selling or giving away chlordiazepoxide may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.

    It is not known if chlordiazepoxide is safe and effective in children under 6 years of age.

    It is not known if chlordiazepoxide is safe and effective for use for longer than 4 months.

    Do not take chlordiazepoxide if you are allergic to chlordiazepoxide or to any of the ingredients in Chlordiazepoxide Hydrochloride Capsules. See the end of this Medication Guide for a complete list of ingredients in Chlordiazepoxide Hydrochloride Capsules.

    Before you take chlordiazepoxide Hydrochloride, tell your healthcare provider about all of your medical conditions, including if you:


    have or have had depression, mood problems, or suicidal thoughts or behavior

    have a history of drug or alcohol abuse or addiction

    have liver or kidney problems

    are pregnant or plan to become pregnant. Chlordiazepoxide may harm your unborn baby. You and your healthcare provider should decide if you should take chlordiazepoxide while you are pregnant

    are breastfeeding or plan to breastfeed. Chlordiazepoxide may pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take chlordiazepoxide .

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Taking chlordiazepoxide with certain other medicines can cause side effects or affect how well chlordiazepoxide or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

    How should I take chlordiazepoxide ?


    Take chlordiazepoxide exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much chlordiazepoxide to take and when to take it.

    If you take too much chlordiazepoxide, call your healthcare provider or go to the nearest hospital emergency room right away.

    What should I avoid while taking chlordiazepoxide ?


    Chlordiazepoxide can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how chlordiazepoxide affects you.

    You should not drink alcohol while taking chlordiazepoxide. Drinking alcohol can increase your chances of having serious side effects.

    What are the possible side effects of chlordiazepoxide ?

    Chlordiazepoxide may cause serious side effects, including:


    See “What is the most important information I should know about chlordiazepoxide ?”

    Abuse and dependence. Taking chlordiazepoxide can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

    Withdrawal symptoms. You may have withdrawal symptoms if you stop taking chlordiazepoxide suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping chlordiazepoxide to avoid withdrawal symptoms.

    The most common side effects of chlordiazepoxide include:


    drowsiness


    loss of control of body movements (ataxia)


    confusion

    These are not all the possible side effects of chlordiazepoxide . Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store Chlordiazepoxide Hydrochloride Capsules ?


    Store Chlordiazepoxide Hydrochloride Capsules at room temperature between 68°F to 77°F (20°C to 25°C).

    Keep Chlordiazepoxide Hydrochloride Capsules in a tightly closed container and out of the light.

    Keep Chlordiazepoxide Hydrochloride Capsules and all medicines out of the reach of children.

    General information about the safe and effective use of Chlordiazepoxide Hydrochloride Capsules.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Chlordiazepoxide Hydrochloride Capsules for a condition for which it was not prescribed. Do not give Chlordiazepoxide Hydrochloride Capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Chlordiazepoxide Hydrochloride Capsules that is written for health professionals.

    What are the ingredients in Chlordiazepoxide Hydrochloride Capsules?

    Active ingredient: chlordiazepoxide hydrochloride

    Inactive ingredients: FD&C Yellow No. 6 plus D&C Yellow No. 10 and either FD&C Blue No. 1 or FD&C Green No. 3 , D&C Yellow No. 10 and either FD&C Blue No. 1 plus FD&C Red No. 3 or FD&C Green No. 3 plus FD&C Red No. 40 , D&C Yellow No. 10 and either FD&C Green No. 3 or FD&C Blue No. 1 (10mg only), FD&C yellow #6 (10mg only), gelatin, hydrogenated vegetable oil, lactose anhydrous, methylparaben, microcrystalline cellulose, propylparaben, silicon dioxide, sodium lauryl sulfate and titanium dioxide

    Distributed by:
    Solco Healthcare U.S., LLC
    Cranbury, NJ 08512


    This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 12/2017

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    CHLORDIAZEPOXIDE 
    chlordiazepoxide capsule, gelatin coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-593(NDC:43547-253)
    Route of Administration ORAL DEA Schedule CIV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORDIAZEPOXIDE HYDROCHLORIDE (UNII: MFM6K1XWDK) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR) CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    TALC (UNII: 7SEV7J4R1U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Color green (GREEN AND WHITE) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code S253;S
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61919-593-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA085475 03/04/2016
    Labeler - DIRECT RX (079254320)
    Establishment
    Name Address ID/FEI Business Operations
    DIRECT RX 079254320 repack(61919-593)
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