Label: VANACOF 2- chlophedianol hcl, dexchlorpheniramine maleate solution

  • NDC Code(s): 58809-190-16
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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  • Active ingredients in each 5 mL (1 teaspoonful)

    Chlophedianol HCI 12.5 mg

    Dexchlorpheniramine Maleate 1 mg

  • Purpose

    Cough Suppressant

    Antihistamine

  • Uses

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

    ■ runny nose

    ■ sneezing

    ■ itching of the nose or throat

    ■ itchy, watery eyes

    ■ cough due to minor throat and bronchial irritation

  • Warnings

    Ask a doctor before use if you have

    ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

    ■ a cough that occurs with too much phlegm (mucus)

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ trouble urinating due to an enlarged prostate gland

    ■ glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    ■ excitability may occur, especially in children

    ■ may cause marked drowsiness

    ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

    ■ avoid alcoholic drinks

    ■ use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    ■ cough 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.

    ■ 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 recommended dosage.

    adults and children 12 years of age and over:

    2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls
    (40 mL) in 24 hours.

    children 6 to under 12 years of age:

    1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls
    (20 mL) in 24 hours.

    children under 6 years of age:consult a doctor.

  • Other information

    ■ this packaging is child-resistant.

    ■ store at room temperature of 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)

  • Inactive ingredients

    citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-190-16

    VanaCof® 2

    EACH 5 mL (1 TEASPOONFUL) CONTAINS:

    Chlophedianol HCI..........................12.5 mg

    Dexchlorpheniramine Maleate............1 mg

    Cough Suppressant

    Antihistamine

    Sugar Free, Alcohol Free, Dye Free

    Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

    THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.

    Dispense in a tight, light-resistant container with a child-resistant cap.

    US Patent # 9,463,191

    US Patent # 9,050,289

    GM Pharmaceuticals, Inc.

    16 fl. oz. (473 mL)

    VanaCof 2 Label

  • INGREDIENTS AND APPEARANCE
    VANACOF 2 
    chlophedianol hcl, dexchlorpheniramine maleate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-190
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-190-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/14/2023
    Labeler - GM Pharmaceuticals, INC (793000860)
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