BRONCOCHEM EXPECTORANT II (ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]

BRONCOCHEM EXPECTORANT II (ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]
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NDC 65131-116-87
Set ID d0426469-9dd1-4bd1-b81e-69d33187daa2
Category HUMAN OTC DRUG LABEL
Packager LABORATORIO MAGNACHEM INTERNATIONAL SRL
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART343
  • Warnings

    Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlem (mucus).  Likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor.  A persistent cough may be a sing of a serious condition. Stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache.  As with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing Pseudoephedrine HCl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Use caution when driving a motor vehicle or operating machinery.

  • Active Ingredients

    Acetaminophen

    Chlorpheniramine Maleate

    Dextromethorphan HBr

    Guaifenesin

    Phenylephrine HCl

  • Purpose

    Analgesic

    Antihistaminic

    Antotussive

    Expectorant

    Decongestant

  • Keep Out Of the Reach Of children

    In case of accidental overdose, seek professional assistancve or contact a poison control center inmediately

  • Indications & Use

    Bronchial congestion

    Irritation of the respiratory passages

    Nasal congestion

    Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive

    Antitussive

    Temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis

  • Dosage and Administration

    Do not exceed 4 doses in a 24 hour period

    Adults and chuildren 12 years and over: (10mL or cc) using metered dosage spoon every 6 hours.

    Children 6 years up to 12 years: (5mL or cc) using metered dosage spoon every 6 hours

  • Drug Interaction Precautions

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI). (certain drugs for depression, psychiatric or emotional conditions, or Parkinson`s disease), or 2 weeks after stopping the MAOI drug.  If you are uncertain whether your presciption drug contains an MAOI, consult a health professional before taking this product

  • Iactive Ingredient

    Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

  • Package Label Principal Display Panel

    BUSAIIBOX

  • Iactive Ingredient

    Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

  • INGREDIENTS AND APPEARANCE
    BRONCOCHEM  EXPECTORANT II
    acetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg  in 10 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 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) PHENYLEPHRINE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 40 mg  in 10 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 20 mg  in 10 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 12 mg  in 10 mL
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) 6 mg  in 10 mL
    DISODIUM HEDTA (UNII: KME849MC7A) 5 mg  in 10 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 2 mg  in 10 mL
    SORBITOL (UNII: 506T60A25R) 2.3 mL  in 10 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2 mL  in 10 mL
    ACETIC ACID (UNII: Q40Q9N063P) 0.016 mL  in 10 mL
    RASPBERRY (UNII: 4N14V5R27W) 0.006 mL  in 10 mL
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.29 mg  in 10 mL
    WATER (UNII: 059QF0KO0R) 10 mL  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65131-116-871 in 1 BOX12/30/2016
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/30/2016
    Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
    Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIO MAGNACHEM INTERNATIONAL SRL871446100manufacture(65131-116)

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