Label: VANACOF DM- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

  • NDC Code(s): 58809-555-08
  • Packager: GM Pharmaceuticals, 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 January 14, 2021

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

  • SPL UNCLASSIFIED SECTION

    Vanacof DM

    NDC 58809-555-08

    8 fl. Oz. (240 mL)

  • Active ingredients (in each 15 mL (TBSP))

    Dextromethorphan HBr 18 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 10 mg 

  • Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      ○ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      ○ the intensity of coughing
      ○ the impulse to cough to help you get to sleep
      ○ nasal congestion due to a cold
  • 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    do not use more than directed

    Stop use and ask a doctor if:

    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent
    • new symptoms occur

    headache. A persistent cough may be a sign of a serious condition.

    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 take more than 6 doses in any 24-hour period
    • use enclosed dosage cup or tablespoon (TBSP)
    • dose as follows or as directed by a doctor
    Adults and children 12 years of age and over:15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period.
    Children 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period.
    Children under 6 years of age:Consult a doctor.
  • Other information

    • Each 15 mL (TBSP) contains: Sodium 8 mg.
    • store at 68-86°F (20-30°C).
  • Inactive ingredients

    citric acid anhydrous, glycerin, masking agent, propylene glycol, purified water, raspberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol

  • Questions or Comments?

    Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

    Distributed by:

    GM Pharmaceuticals, Inc.

    Arlington, TX 76015

    KEEP LEAFLET AFTER OPENING

    Rev. 09/16

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-55-08
    VANACOF DM
    Cough
    Cold/Congestion
    Raspberry Flavor
    8 fl. oz. (240 mL)

    PRINCIPAL DISPLAY PANEL
NDC 58809-55-08
VANACOF DM
Cough
Cold/Congestion
Raspberry Flavor
8 fl. oz. (240 mL)

    PRINCIPAL DISPLAY PANEL
NDC 58809-55-08
VANACOF DM
Cough
Cold/Congestion
Raspberry Flavor
8 fl. oz. (240 mL)

    PRINCIPAL DISPLAY PANEL
NDC 58809-55-08
VANACOF DM
Cough
Cold/Congestion
Raspberry Flavor
8 fl. oz. (240 mL)

  • INGREDIENTS AND APPEARANCE
    VANACOF DM 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-555
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE18 mg  in 15 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-555-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2013
    Labeler - GM Pharmaceuticals, INC (793000860)