Label: BIOGTUSS- dextromethorphan, guaifenesin, phenylephrine liquid

  • NDC Code(s): 45737-205-16
  • Packager: Advanced Generic Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 23, 2020

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

  • 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)