Label: BIOTPRES PEDIATRIC- dextromethorphan, guaifenesin, phenylephrine liquid

  • NDC Code(s): 45737-227-16
  • 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

    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)