BIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]

BIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]
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NDC 45737-230-01
Set ID b3b9c298-4524-4ba7-a831-3bf3c2950e27
Category HUMAN OTC DRUG LABEL
Packager Advanced Generic Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients (in each 1mL)                   Purpose

    Dextromethorphan HBr, 5 mg ................................. Cough Suppressant

    Guaifenesin, 50 mg ................................................ Expectorant

    Phenylephrine HCl, 2.5 mg ...................................... Nasal Decongestant



  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • WARNINGS

    Warnings:


    Do not exceed recommended dosage.

    • If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
    • If symptoms do not improve within 7 days or accompanied by fever, consult a doctor.
  • DO NOT USE

    • Do not use this product:for persistent or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
    • in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
    • Do not give this product to child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
    • Stop use and ask a doctor:
    • A persistent cough may be a sign of a serious condition;
    • If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:Do not exceed more than 6 doses in any 24-hour period. Measure with the dosage device provided. Do not use with any other device.

    Age
    Dose
    Children 2 to under 6 years of age
    1 mL every 4 hours
    Children under 2 years of age
    Consult a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients:Artificial  and natural Cherry Flavor, Citric Acid, FD and C Red No. 40, Glycerin, Methyl Paraben (as preservative), Propylene Glycol, Propylparaben (as preservative), Purified Water, sodium citrate, and sucralose

  • QUESTIONS

    Questions or comments? 1-305-403-3788

  • INDICATIONS & USAGE

    Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.

  • PRINCIPAL DISPLAY PANEL

    biospres

  • INGREDIENTS AND APPEARANCE
    BIO-S-PRES  DX
    dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-230
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-230-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2013
    Labeler - Advanced Generic Corporation (831762971)