Label: BRONCOMAR- acetaminophen, 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 June 23, 2014

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

  • ACTIVE INGREDIENT

    Acvtive ingredients: (in 10 ml)              Purpose

    Acetaminophen 200 mg ............................. Analgesic

    Dextromethorphan HBr 13.33 mg ................... Cough Suppressant

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

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

  • PURPOSE

    Purpose

    Analgesic

    Cough Suppressant

    Expectorant

    Decongestant

  • INDICATIONS & USAGE

    Uses

    • For temporary relief of bronchial and nasal congestion
    • Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
    • Teporarily 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 contains Acetaminophen. Sever liver damage may occur if

    • 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 everyday 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

    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 the MAOI drug.
    • if you do not know if your prescription drug contains on MAOI ask 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 beverages while you are taking this product
    • do not use with any other drug containing Acetaminophen (prescirption or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a doctor or a pharmacist.

    Ask the doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • heart disease, high blood pressure, thyroid disease, or difficulty in urination due to the enlargement of prostate gland.
    • The user has liver disease
    • The user is taking the blood thinning drug Warfarin.

  • STOP USE

    Stop use and ask the doctor if

    • Nervoisness, dizziness or sleeplessness occurs.
    • Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition
  • 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 take more than 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 tsps) every 6 hours

    Children under 6 years of age                       Do not use

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe vera, citric acid, disodium EDTA, FD&C Red #40, hydroxyethyl cellulose, natural strawberry flavor, propylene glycol, water, sodium benzoate, sorbitol 70%, sucralose

  • PRINCIPAL DISPLAY PANEL

    BroncomarEx

  • INGREDIENTS AND APPEARANCE
    BRONCOMAR 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-215
    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 WHOLE (UNII: KIZ4X2EHYX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-215-061 in 1 CARTON
    1177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2014
    Labeler - Gadal Laboratories Inc (841305639)