Label: EXPECTORANT PLUS COUGH RELIEF- guaifenesin and dextromethorphan granule

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 6, 2010

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  • Active Ingredients (in each packet)

    Dextromethorphan HBr 5mg

    Guaifenesin 100mg


  • Purpose

    Cough Suppressant

    Expectorant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    ■ temporarily relieves:
    ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    ■ the intensity of coughing
    ■ the impulse to cough to help you get to sleep

  • Warnings

     

    Do not use 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

    ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    ■ cough that occurs with too much phlegm (mucus)

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

    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

    ■ empty entire contents of packet onto tongue and swallow with a glass of water
    ■ for best taste, do not chew granules
    ■ do not take more than 6 doses in any 24-hour period

    Age
    		Dose
    adults and children 12 years and over
    		2 to 4 packets every 4 hours
    children 6 years to under 12 years
    		1 to 2 packets every 4 hours
    children 4 years to under 6 years
    		1 packet every 4 hours
    children under 4 years
    		do not use
  • Other information

    ■ store between 20-25°C (68-77°F).
    ■ tamper evident: do not use if carton is open or if packets are torn or open.
    ■ see below for lot number and expiration date

  • Inactive Ingredients

    cocoa butter, confectioners sugar, crospovidone, lactose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, modified cornstarch, flavor, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sorbitan monostearate, starch, sucralose, sugar, talc, triethyl citrate
  • Principal Display Panel

    Capricorn Pharma
    ORIGINAL DEVELOPERS AND MANUFACTURERS

    Compare to the active ingredients of Mucinex Cough Mini-Melts

    FOR KIDS
    For ages 4-12

    Expectorant plus Cough Relief

    DEXTROMETHORPHAN HBr 5mg - Cough Suppressant
    GUAIFENESIN 100mg - Expectorant

    Relieves Chest Congestion
    Thins and loosens mucus
    Controls cough
    Great taste, Easy to Take

    FLASHBEADS

    12 Packets

    Orange Flavor

    Guaifenesin and Dextromethorphan



  • INGREDIENTS AND APPEARANCE
    EXPECTORANT PLUS COUGH RELIEF 
    guaifenesin and dextromethorphan granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66007-204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
    Product Characteristics
    Colorwhite (White to off-white) Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66007-204-0112 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/06/2010
    Labeler - Capricorn Pharma Inc. (041704524)
    Registrant - Capricorn Pharma Inc. (041704524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Capricorn Pharma Inc.041704524manufacture
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