Label: BRONCOMAR EXPECTORANT- acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl 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

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

  • ACTIVE INGREDIENT

    Active Ingredients:(in each 10 ml.)Purpose

    Acetaminophen 250 mg ........................................................

    Analgesic

    Dextromethorphan Hydrobromide 13.33 mg .......................

    Cough Suppressant

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

    Expectorant

    Phenylephrine HCl 5 mg.......................................................

    Decongestant

  • PURPOSE

    Uses:

    • For temporary relief og Bronchial and Nasal congestion
    • 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


    Liver Warning this product contatins Acetaminophen. Severe liver damage may occur if

  • DO NOT USE


    • Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
    • Child takes more than 5 doses in 24 hours
    • Taken with other drugs containing Acetaminophen.
    • Adult has 3 or more alcoholic drinks every day while using this product
    • Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
    • 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.
    • Do not use with any other drug containing Acetaminophen (prescription no nonprescription) If you are not sure whether a drug contains Acetaminophen, ask a doctor or pharmacist

    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.
    • Heart disease, high blood pressure, thyroid disease, or difficulty in urination due enlargement of prostate gland.
    • The user has Liver diseases
    • The user us taking the blood thinning drug Warfarin
  • 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, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Propylene Glycol USP, 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 EXPECTORANT Label

  • INGREDIENTS AND APPEARANCE
    BRONCOMAR  EXPECTORANT
    acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE13.33 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70242-102-061 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(70242-102)