BIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]

BIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]
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NDC 45737-205-16
Set ID 28c143f4-1575-44fe-871c-8e281322994e
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

    Guaifenesin 300 mg .............................................. Expectorant

    Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

    Phenylephrine HCl 10 mg.................................. Decongestant

  • PURPOSE

    Uses
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus
    • temporarily relieves nasal congestion and cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants.
  • WARNINGS

    Warnings

    • Do not exceed recommended dosage
    • A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reoccur or is accompanied by a fever, rash or persistent headache, consult a doctor
    • May cause or aggravate constipation
    • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
    • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
  • DO NOT USE

    Do not Use

    • For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor
    • If you have a chronic pulmonary disease or shortness of breath, children who are taking other drugs, unless directed by a doctor.  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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.


    If you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to the enlargement of the prostate gland unless directed by a doctor.
  • 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 6 doses in 24 hours.

    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

  • INDICATIONS & USAGE

    Other information  store at room temperature 15°- 30°C (59° - 86°F).

    Tamper Evident Feature:
    Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

    Warning:Phenylketonuric. Contains 17 mg of Phenylalanine per 5 mL (one teaspoonful dose).

  • INACTIVE INGREDIENT

    Inactive Ingredients aspartame, citric acid, D and C Red No 33, FD and C Blue No 1, glycerine, hydroxymethyl cellulose, methylparaben, natural and artificial flavors, propylene glycol, propylparaben, purified water, sodium citrate

  • QUESTIONS

    Questions or comments? 1-305-403-3788

    Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

    www.advancedgeneric.com

  • PRINCIPAL DISPLAY PANEL

    BioGtussLabel

  • INGREDIENTS AND APPEARANCE
    BIOGTUSS 
    dextromethorphan, guaifenesin, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-205
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin300 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Aspartame (UNII: Z0H242BBR1)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Hydroxymethyl Cellulose (UNII: 273FM27VK1)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-205-16473 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)