Label: BIDEX-400 - guaifenesin tablet 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

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

  • Drug Facts

    Active ingredient
    (in each immediate release tablet)
    Guaifenesin 400 mg

    Purpose

    Expectorant
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  • Uses

    Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
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  • Warnings


    Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • a cough that occurs with too much phlegm (mucus)

    Stop use and ask doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  A persistent cough may be a sign of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.
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  • Directions

    Adults and children 12 years
    of age and over:
    1 tablet every 4 hours, not to
    exceed 6 tablets in 24 hours.
    Children under 12 years of age:
    consult a doctor.
    ·Take with a full glass of water Close
  • Other information

    • Tamper-evident by foil seal under cap.  Do not use if foil seal is broken or missing
    • Store between 20°-25°C (68°-77°F).
    • Supplied in a tight, light-resistant container with a child-resistant cap.
    • Bidex-400 Tablets are white to off white, biconex, capsule shaped tablets, debossed "649" bisect "649" on one side and plain on the other side.
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  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid.  May also contain sodium starch glycolate.
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  • Questions or comments?

    1 (877) 604-7575

    Distributed by:
    SJ Pharmaceuticals
    4200 North Parkway NW, Bldg. 12
    Atlanta, GA  30327

    Rev. 10/12
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  • Product Packaging

    The packaging below represents the labeling currently used.

    Principal display panel for 100 tablets label:

    NDC 24839-777-01

    BIDEX®-400
    TABLETS


    Each immediate release tablet contains:
    Guaifenesin.......................400 mg

    Expectorant

    CONTENTS:  100 Tablets

    SJP

    SJ PHARMACEUTICALS



    BIDEX-400 Tablets Packaging

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  • INGREDIENTS AND APPEARANCE
    BIDEX-400 
    guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24839-777
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (Guaifenesin) Guaifenesin 400 mg
    Inactive Ingredients
    Ingredient Name Strength
    Silicon Dioxide  
    Croscarmellose Sodium  
    Hypromelloses  
    Maltodextrin  
    Povidones  
    Cellulose, Microcrystalline  
    Stearic Acid  
    Product Characteristics
    Color white (white to off white) Score 2 pieces
    Shape CAPSULE Size 15mm
    Flavor Imprint Code 649;649
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24839-777-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/09/2012
    Labeler - SJ Pharmaceuticals (845662720)
    Registrant - Pernix Manufacturing, LLC (078641814)
    Establishment
    Name Address ID/FEI Business Operations
    Pernix Manufacturing, LLC dba Great Southern Laboratories 078641814 manufacture(24839-777)
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