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

BIOTPRES PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]
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NDC 45737-227-16
Set ID d6b2d191-e2fb-4da4-92e0-35b81e07e673
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

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

    Guaifenesin 75 mg .............................................. Expectorant

    Phenylephrine HCl 2.5 mg.................................. Decongestant

  • PURPOSE

    Uses
    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with common cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus
    • temporarily relieves nasal congestion due to the common cold and cough due to minor throat and bronchial irritation.
  • 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.

  • DO NOT USE

    Do not Use

    • In a child under 2 years of age.

    Ask a doctor before use if child has
    • 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)
    • cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema
    When using this product, do not exceed recommended dosage

    Stop use and ask a doctor if your child

    •  gets nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or are 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 serous 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 6 doses in 24 hours.

    adults and children 12 years of age and over take 4 teaspoonful (20 mL) every 4 hours

    children 6 to under 12 years of age take 2 teaspoonful (10 mL) every 4 hours

    children 2 to under 6 years of age take 1 teaspoonful (5 mL) every 4 hours

    children under 2 years of age ask doctor

  • INDICATIONS & USAGE


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

    Tamper evident by imprinted heat seal under cap. Do not use if there's evidence of tampering.

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

  • INACTIVE INGREDIENT

    Inactive Ingredients aspartame, citric acid,natural and artificial flavors, glycerine, methylparaben,natrosol, 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

    BioTPresPedLabel

  • INGREDIENTS AND APPEARANCE
    BIOTPRES  PEDIATRIC
    dextromethorphan, guaifenesin, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-227
    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) Guaifenesin75 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydroxymethyl Cellulose (UNII: 273FM27VK1)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGE (Orange Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-227-16473 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)