Temazepam by AvKARE TEMAZEPAM capsule

Temazepam by

Drug Labeling and Warnings

Temazepam by is a Prescription medication manufactured, distributed, or labeled by AvKARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • DOSAGE AND ADMINISTRATION

    While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

  • HOW SUPPLIED

    Temazepam capsules USP

    7.5 mg

    White opaque/turquoise opaque capsules imprinted "Mutual 866".

    Bottles of 100NDC: 42291-797-01

    15 mg

    White opaque/green opaque capsules imprinted "Mutual 867".

    22.5 mg

    White opaque/light green opaque capsules imprinted "Mutual 868".

    30 mg

    White opaque/white opaque capsules imprinted "Mutual 869".

    Store at 20° to 25°C (68° to 77°F).

    [See USP Controlled Room Temperature]

    DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    AvKARE, Inc.
    Pulaski, TN  38478

    Mfg. Rev. 07/14
    AV  08/15 (P)

  • MEDICATION GUIDE

    TEMAZEPAM CAPSULES USP C-IV

    Read the Medication Guide that comes with temazepam capsules before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

    What is the most important information I should know about temazepam capsules?

    After taking temazepam capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with temazepam capsules. Reported activities include:

    Call your doctor right away if you find out that you have done any of the above activities after taking temazepam capsules.

    Important:

    1. Take temazepam capsules exactly as prescribed

    2. Do not take temazepam capsules if you:

    What are temazepam capsules?

    Temazepam capsules are a sedative-hypnotic (sleep) medicine. Temazepam capsules are used in adults for the short-term (usually 7 to 10 days) treatment of a sleep problem called insomnia. Symptoms of insomnia include:

    Temazepam capsules are not for children.

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

    Who should not take temazepam capsules?

    Do not take temazepam capsules if you are pregnant or planning to become pregnant. Temazepam capsules may cause birth defects or harm a fetus (unborn baby).

    Temazepam capsules may not be right for you. Before starting temazepam capsules, tell your doctor about all of your health conditions, including if you:

    Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take temazepam capsules with other medicines that can make you sleepy.

    Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

    How should I take temazepam capsules?

    What are the possible side effects of temazepam capsules?

    Possible serious side effects of temazepam capsules include:

    Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using temazepam capsules.

    The most common side effects of temazepam capsules are:

    These are not all the side effects of temazepam capsules. Ask your doctor or pharmacist for more information.

    How should I store temazepam capsules?

    General Information about temazepam capsules

    This Medication Guide summarizes the most important information about temazepam capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about temazepam capsules that is written for healthcare professionals.

    What are the ingredients in temazepam capsules?

    Active Ingredient: temazepam USP

    Inactive Ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin and titanium dioxide. The capsule shell for the 7.5 mg also contains FD&C Blue #1 and FD&C Red #40; the capsule shell for 15 mg and 22.5 mg also contains D&C Yellow #10, FD&C Blue #1 and FD&C Yellow #6. The imprinting ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black and propylene glycol.

    Rx only

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

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

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    AvKARE, Inc.
    Pulaski, TN  38478

    Mfg. Rev. 07/14
    AV  08/15 (P)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    AvKARE

    NDC
    42291-797-01

    Temazepam Capsules USP CIV

    7.5mg

    100 Capsules          Rx Only

    PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE ATTACHED.

    Each Capsule Contains:
    Temazepam, USP ........................ 7.5 mg

    USUAL DOSAGE:
    Read package outsert for full prescribing information.

    Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

    DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

    Capsule Imprinted: Mutual 866

    Keep out of the reach of children.

    Manufactured for:
    AvKARE, Inc.
    Pulaski, TN 38478

    Mfg. Rev. 02, 07/14          AV 08/15 (P)

    N3   42291 79701   7

    7.5 label
  • INGREDIENTS AND APPEARANCE
    TEMAZEPAM 
    temazepam capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 42291-797(NDC:53489-648)
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS) TEMAZEPAM7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (opaque) , turquoise (opaque) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code Mutual;866
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 42291-797-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07858108/25/2015
    Labeler - AvKARE, Inc. (796560394)

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