Label: DESPEC DM- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

  • NDC Code(s): 11584-1046-4
  • Packager: International Ethical Laboratories, Inc
  • 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 March 1, 2021

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

  • Drug Facts

    Active ingredients ( in each 5 mL teaspoonful)

    Dextromethorphan Hydrobromide 10mg

    Guaifenesin 100mg

    Phenylephrine Hydrochloride 5mg

  • Purpose

    Antitussive/ Expectroant/ Nasal Decongestant

  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • nasal congestion
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage

  • Do not use this product

    • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emtional conditions, or Parkinson's disease). or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness, occur
    • cough or nasal congestion persists for more than 1 week, trends to recur, or persistent headache. A persistent cough may be a sign of a serious condition.
    • new symptoms occur
  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not exceed recommeneded dosage.

    • Use with enclosed dosage cup.

    Adults and children 12 years of age and over------2 teaspoonfuls ( 2 TSP) every 4 hours, not to exceed 6 doses in 24 hours.

    Children 6 to under 12 years of age........1 teaspoonful (1 TSP) every 4 hours, not to exceed 6 doses in 24 hours.

    Children under 6 years of age....... Consult a doctor

  • Other information

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

  • Inactive ingredients

    Citric acid, glycerin, grape flavor, maltitol, propylene glycol, purified water, sodium citrate, sodium saccharin and sorbitol.

  • Questions? Comments?

    call 1-787-765-3510

  • Principal Display Panel-Label

    BookletBase labelPrincipal Display Panel-120 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    DESPEC  DM
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11584-1046
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    MALTITOL (UNII: D65DG142WK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11584-1046-4120 mL in 1 BOTTLE; Type 0: Not a Combination Product02/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/19/2014
    Labeler - International Ethical Laboratories, Inc (091176933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodfield Pharmaceutical, LLC079398730manufacture(11584-1046)