Label: BIONEL PEDIATRIC- dextromethorphan, guaifenesin, pseudoephedrine hydrochloride liquid

  • NDC Code(s): 45737-207-16
  • Packager: Advanced Generic Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients: (in each 5 mL tsp.)              Purpose

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

    Dextromethorphan Hydrobromide 5 mg.................. Cough Suppressant

    Pseudoephedrine HCl 15 mg.................................. Nasal Decongestant

  • PURPOSE

    Uses


    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily relieves these symptoms occurring with a cold: nasal congestion, cough due to minor throat and bronchial irritation.

  • WARNINGS

    Warnings
    Do not usein a child who is 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 you are
    taking a prescription drug that contains a MAOI; ask a doctor or
    pharmacist before taking this product.

  • DO NOT USE

    Ask a doctor before use if your child hav

    e


    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to the enlargement of the prostate gland
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.

    Stop use and ask a doctor if


    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or accompanied by fever
    • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

    Children 6 to under 12 years of age; 45 lbs to under 95 lbs; Take 2 teaspoonfuls (10mL) every 4 to 6 hours

    Children 2 to under 6 years of age; 25 lbs to under 45 lbs; Take 1 teaspoonful (5mL) every 4 to 6 hours

    Children under 2 years of age; Under 25 lbs; Ask a doctor

  • INDICATIONS & USAGE

    Other information


    • store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.

    Warning: Phenylketonuric: Contains 14 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

  • INACTIVE INGREDIENT

    Inactive ingredientsaspartame, citric acid, corn syrup, D and C Red No 33, methylparaben, natural and artificial flavors, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water.

  • QUESTIONS

    Questions or comments?1-305-403-3788

    Manufactured For:Advanced Generic Corporation, Miami, Fl 33166

    www.advancedgeneric.com

  • PRINCIPAL DISPLAY PANEL

    BionelPedLabel

  • INGREDIENTS AND APPEARANCE
    BIONEL  PEDIATRIC
    dextromethorphan, guaifenesin, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-207
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ASPARTAME (UNII: Z0H242BBR1)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-207-16473 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 DrugM01210/01/2009
    Labeler - Advanced Generic Corporation (831762971)