BRONCOMAR EXPECTORANT (ACETAMINOFEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]

BRONCOMAR EXPECTORANT (ACETAMINOFEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]
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NDC 70242-102-06
Set ID fef0c576-5fe2-42c5-9c4f-47dab6e940bb
Category HUMAN OTC DRUG LABEL
Packager Dannso Corp./d.b.a. Essential Products
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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)

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