BRONCOMAR (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GADAL LABORATORIES INC]

BRONCOMAR (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GADAL LABORATORIES INC]
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NDC 53113-215-06
Set ID 058cdaf3-ed98-44b2-9ecc-fd810dcac12e
Category HUMAN OTC DRUG LABEL
Packager Gadal Laboratories Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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)

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