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CAPMIST (Capital Pharmaceutical)

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TABLET 90 TABLET in 1 BOTTLE (29978-606-90) Label Information

Complete CAPMIST Information

  • Drug Facts

    Active ingredients
    (in each tablet)
    Dextromethorphan HBr 30 mg
    Guaifenesin 400 mg
    Pseudoephedrine HCl 30 mg

  • Purpose

    Cough Suppressant
    Expectorant
    Nasal Decongestant

  • Description

    Capmist DM is a green, oblong, capsule shaped, scored tablet, imprinted CAP DM on one side and blank on the other.

  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • nasal congestion
    • reduces swelling of nasal passages

  • Warnings

    Do not exceed recommended dosage.
  • Do not use this product

    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

  • 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)
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlargement of the prostate gland

  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  A persistent cough may be a sign of a serious condition.
    • new symptoms occur

  • 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.
  • Directions

    Do not exceed recommended dosage.
    Adults and children
    12 years of age
    and over:
    1 tablet every 6 hours, not
    to exceed 4 tablets in 24
    hours.
    Children 12 years
    of age and younger:
    Consult a doctor.



  • Other information

    Store at 15° - 30°C (59° - 86°F).

    Capmist DM is a light green, oblong, capsule shaped, scored tablet, debossed "CAP" bisect "DM" on one side
    and blank on the other.

    Contains color additives including FD&C Yellow No. 5 (tartrazine).

    Supplied in a tight, light-resistant container with a child-resistant cap.

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, hypromellose, maltodextrin, povidone, slicified microcrystalline cellulose, and stearic acid.

  • Questions? Comments?

    Serious side effects may be reported to this
    number.  Call 1 (614) 638-4622.

    Manufactured for:                                                       
    Capital Pharma                                           
    Powell, OH  43065 

    Manufactured by:
    Great Southern Laboratories
    Houston, TX  77099                                                

    Rev. 02/12            

  • Product Packaging

    The packaging below represents the labeling currently used:

    Principal display panel and side panel for 90 tablets labeling:

    NDC 29978-606-90                 

    CAPMIST DM
    TABLETS

    COUGH SUPPRESSANT · EXPECTORANT
    NASAL DECONGESTANT

    Each tablet contains:
    Dextromethorphan HBr.........................30 mg
    Guaifenesin.......................................400 mg
    Pseudoephedrine HCl...........................30 mg

    CAPITAL
    pharmaceutical              90 tablets

    Tamper evident by foil seal under cap.
    Do not use if foil seal is broken or missing.

    Distributed by:  Capital Pharma, Powell, OH  43065
    1 (614) 638-4622                      Rev. 02/12


    CAPMIST DM TABLETS Packaging


    CAPMIST DM TABLETS Packaging


    CAPMIST DM TABLETS Packaging


  • INGREDIENTS AND APPEARANCE
    CAPMIST  DM
    dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:29978-606
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 30 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Povidones (UNII: FZ989GH94E)  
    Product Characteristics
    Color green Score 2 pieces
    Shape CAPSULE Size 19mm
    Flavor Imprint Code CAP;DM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29978-606-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/27/2011
    Labeler - Capital Pharmaceutical (831545541)
    Registrant - Pernix Manufacturing, LLC (078641814)
    Establishment
    Name Address ID/FEI Business Operations
    Pernix Manufacturing, LLC dba Great Southern Laboratories 078641814 manufacture(29978-606)