Label: VANACOF XP COUGH / CHEST CONGESTION- dextromethorphan hbr, guaifenesin solution

  • NDC Code(s): 58809-187-08
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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  • Active Ingredients (in each 15 mL (1TBSP))

    Dextromethorphan HBr 18 mg

    Guaifenesin 396 mg

  • Purpose

    Cough Suppressant

    Expectorant

  • 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

  • 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 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)

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs 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
    • ■ dose as follows or as directed by a doctor ■ mL= milliliter
    adults and children 12 years of age and over:

    15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) per 24 hours
    children 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours
    children under 6 years:consult a doctor.

  • Other information

    ■ each 15 mL (1 TBSP) contains: Sodium 6 mg

    ■ store at 20° to 30°C (68° to 86°F)

  • Inactive ingredients

    citric acid, flavors, glycerin, l-menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Tamper evident by foil seal under cap. Do no use if foil seal is broken or missing.

    Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-187-08

    VANACOF® XP

    COUGH / CHEST CONGESTION

    Each 15 mL (1 TBSP) contains:

    Dextromethorphan HBr.....18 mg

    Guaifenesin ....................396 mg

    Cough Suppressant ■ Expectorant

    Raspberry-Mint Flavor

    Alcohol Free / Sugar Free / Gluten Free / Dye Free

    VanaCof XP Label

  • INGREDIENTS AND APPEARANCE
    VANACOF XP COUGH / CHEST CONGESTION 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-187
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN396 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE18 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    MENTHOL (UNII: L7T10EIP3A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRY, MINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-187-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/06/2023
    Labeler - GM Pharmaceuticals, INC (793000860)
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