Label: BRONCOMAR MAXIMUN COUGH RELIEF- dextromethorphan hbr, guaifenesin liquid

  • 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 January 1, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients:(in each 10 ml.)Purpose

    Dextromethorphan Hydrobromide 30 mg ....................

    Cough Suppressant

    Guaifenesin 200 mg.......................................................

    Expectorant
  • PURPOSE

    Uses:

    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
  • WARNINGS

    Warnings

    Do not exceed recommended dosage

  • DO NOT USE


    Do not use

    • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric conditions, or Parkinson's disease) or for 2 weeks after stopping MAOI drug.
    • If you do not know if your prescription drug contains MAOI as your doctor or pharmacist before taking this product.
    • If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
    • Avoid alcoholic beverage while taking this product.

    Stop use and ask a doctor
    • Nervousness, dizziness or sleeplessness occurs.
    • Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.
  • ASK DOCTOR

    Ask doctor before use if you have

    • Cough that occurs with too much phlegm(mucus)
    • Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • PREGNANCY OR BREAST FEEDING

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


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Do not exceed 6 doses in any 24 hour period.

    AGE
    		DOSE
    Adults and Children 12 years and over
    		10 ml (2 tsps) every 6 hours
    Children 6 to under 12 years of age
    		5 ml (1 tsp) every 6 hours
    Children under 6 years of age
    		Do not  use



  • INDICATIONS & USAGE

    Other Information:

    • Each 10 mls contains: sodium 4 mg
    • Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
    • Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.
  • Inactive Ingredient

    Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Glycerin, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.

  • Questions or Comments

    Call Weekdays from 9:30 AM to 5PM EST at Tel 305-261-762

    Distributed by

    Essential Products Miami FL 33126

    www.jjjdistributors.com

    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL

    Broncomar Maximun Cough Label

  • INGREDIENTS AND APPEARANCE
    BRONCOMAR  MAXIMUN COUGH RELIEF
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70242-103-061 in 1 CARTON01/01/2015
    1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2001
    Labeler - Dannso Corp./d.b.a. Essential Products (059741071)
    Registrant - Dannso Corp./d.b.a. Essential Products (059741071)
    Establishment
    NameAddressID/FEIBusiness Operations
    All Pharma LLC078572520MANUFACTURE(70242-103)
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