Label: DESPEC EDA DROPS- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

  • 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 October 15, 2018

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  • ACTIVE INGREDIENT

    Active ingredients:
    (in each 1 mL dropperful)
    Dextromethorphan Hydrobromide 5 mg
    Guaifenesin 50 mg
    Phenylephrine Hydrochloride 2.5 mg

  • PURPOSE

    Purpose:

    Antitussive
    Expectorant
    Nasal Decongestant

  • INDICATIONS & USAGE

    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

    Warnings:

    Do not exceed recommended dosage.

    Do not use this product

    in a 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 an MAOI, ask a doctor or pharmacist before giving this product.

  • ASK DOCTOR

    Ask a doctor before use if the child has:

    a cough that lasts or is chronic such as occurs with asthma
    a cough that occurs with too much phlegm (mucus)
    heart disease
    high blood pressure
    thyroid disease
    diabetes

  • STOP USE

    Stop use and ask a doctor if:

    cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
    nervousness, dizziness, or sleeplessness occur

    new symptoms occur

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions:

    Administer using provided dropper.

    AGE

    DOSE

    Children 2 to under
    6 years of age:

    1 dropperful (1 mL) every 4 hours,
    not to exceed 6 dropperfuls in 24
    hours

    Children under 2 years of age:

    Consult a physician

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Bitter Mask, Citric Acid, Glycerin, Grape Flavoring, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose.

  • OTHER SAFETY INFORMATION

    Other information:

    Store at 59° - 86°F (15° - 30°C)

  • QUESTIONS

    Questions? Comments?

    Call 1-787-765-3510

    Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
    Dispensed in a tight, light-resistant container with a child-resistant cap.
    Manufactured For:
    International Ethical Labs
    San Juan, PR 00918-2627

    Rev. 04/10/17

  • Product Packaging

    DESPEC EDA DROPS - FRONTDESPEC EDA DROPS - BACK

  • INGREDIENTS AND APPEARANCE
    DESPEC  EDA DROPS
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11584-1110
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11584-1110-130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/19/2012
    Labeler - International Ethical Labs (091176933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodfield Pharmaceuticals, LLC079398730manufacture(11584-1110)
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