Label: DESGEN PEDIATRIC- dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ drops

  • Category: HUMAN OTC DRUG LABEL

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 September 16, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients (in each 1 mL)                    Purpose

    Dextromethorphan HBr, 5 mg..............................Antitussive

    Guaifenesin, 50 mg..............................................Expectorant

    Phenylephrine HCl, 2.5 mg................................Nasal decongestant



  • PURPOSE

    Uses
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily relieves:
    • nasal congestion due to the common cold
    • cough due to minor throat and bronchial irritation as may occur with the common cold
  • WARNINGS


    Warnings

    Do not use
    in child who is 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 your child's prescription drug contains a MAOI, ask a doctor or pharmacist before giving this product.

  • DO NOT USE


    Ask a doctor before use if your child has
    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • a cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with asthma

    When using this product do not exceed recommended dosage
    Stop use and ask a doctor if
    • new symptoms occur
    • your child gets nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING


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


  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION


    Directions

    do not use more than 6 doses in any 24-hour period

    Children 2 to under 5 years of age

    • 1 mL every 4 hours, do not exceed 6 doses, or as directed by a doctor.

    Children under 2, consult a doctor.

    • measure with the dosage device provided. Do not use any other device.
  • INDICATIONS & USAGE


    Other information

    Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.

    Store at controlled room temperature 15-30°C (59-86°F).

    Avoid excessive heat and humidity.

  • INACTIVE INGREDIENT


    Inactive ingredients     Citric acid, flavors, glycerin, methyl paraben, polyethylene glycol, propylene glycol, propyl paraben, purified water, sodium citrate, sorbitol and sucralose.

  • QUESTIONS

    Manufactured in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072

  • Principal Display Panel

    DESGEN

    PEDIATRIC DROPS

    Contains the same active ingredients as Despec® EDA drops

    Antitussive

    Expectorant

    Nasal Decongestant

    Sugar, Alcohol & Dye Free

    NET CONTENT: 30 mL (1 Fl. Oz.)

    KRAMER-NOVIS

    kramer-supress-pe

  • INGREDIENTS AND APPEARANCE
    DESGEN  PEDIATRIC
    dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-641
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-641-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/27/2014
    Labeler - Kramer Novis (090158395)
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