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

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

BIOGTUSS NF (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]
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NDC 45737-242-16
Set ID 17414989-bc15-405d-b893-028250d5becf
Category HUMAN OTC DRUG LABEL
Packager Advanced Generic Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • ACTIVE INGREDIENT

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

    Dextromethorphan HBr 28 mg.................. Cough Suppressant

    Guaifenesin 388 mg .............................................. Expectorant

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

  • PURPOSE

    Purpose

    Cough suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    • temporary relieves cough due to minor throat and bonchial irritations as may occur with the common cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretaions to make cough more productive
    • temporarily relieves nasal congestion due to the common cold.
  • 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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of 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 doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • 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 accidental overdose, seek advice or a doctor or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions Do not exceed 6 doses in 24 hours.

     adults and children over 12 years of agetake 1 teaspoonful (5 mL) every 6-8 hours 
    children 6 to under 12 years of age take 1/2 teaspoonful (2.5 mL) every 6-8 hours
    children under 6 years of age consult a doctor before use

  • INACTIVE INGREDIENT

    Inactive Ingredients  citric acid, FDandC yellow No 6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

  • QUESTIONS

    Questions or comments? 1-305-403-3788

    Monday - Friday 9:00AM - 5:00 PM EST.

    Manufactured For: Advanced Generic Corporation, Miami, Fl 33147

    www.advancedgeneric.com

  • PRINCIPAL DISPLAY PANEL

    BioGtussNFLabel

  • INGREDIENTS AND APPEARANCE
    BIOGTUSS  NF
    dextromethorphan, guaifenesin, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide28 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin388 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    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
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-242-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2010
    Labeler - Advanced Generic Corporation (831762971)
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