VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC]

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  • VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC]

VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC]
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NDC 58809-555-08
Set ID 2ed699f2-d004-4fa9-8042-6c85a9ff69b6
Category HUMAN OTC DRUG LABEL
Packager GM Pharmaceuticals, INC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • 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)
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