BIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]

BIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]
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NDC 45737-210-16
Set ID e57de19a-bf2f-405c-bc84-6ccae6055a46
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 5 mL tsp.)                                           Purpose

    Dexbrompheniramine Maleate.............2mg................................Antihistamine

    Dextromethorphan HBr..................20mg.................................Cough Suppressant

    Phenylephrine HCL......................10mg................................. Nasal Descongestant

  • PURPOSE

    Purpose

    Antihistamine

    Cough Suppressant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    • helps to control the relex that causes coughing
    • temporarily relieves nasal congestion due to common cold, hay fever, or other upper respiratory allergies (allergic rhinitis)
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • WARNINGS

    Warnings:

    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 for 2 weeks after stopping the MAOI drug. If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before using the product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a docotor before use if you are taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dose
    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occurs
    • cough lasts for more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.
    • These could be signs of a serious condition.
  • 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions: Do not exceed more than 6 doses in any 24-hour period or
    as directed by a doctor.

      Adults and children
     12 years of age and over
      take 1 teaspoonful (5 mL)
     every 4 hours
      Children 6 to under
     12 years of age
      take 1/2 teaspoonful (2.5 mL)
     every 4 hours
      Children under 6 years of age
      ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients: artificial flavor, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, water, sodium citrate and sucralose.

  • QUESTIONS

    Questions or comments? 1-305-403-3788

  • PRINCIPAL DISPLAY PANEL

    bionatusslabel

  • INGREDIENTS AND APPEARANCE
    BIONATUSS  DXP
    dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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
    FlavorRASPBERRY (Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-210-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2009
    Labeler - Advanced Generic Corporation (831762971)