Label: VANACOF- chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid

  • NDC Code(s): 58809-999-01, 58809-999-02
  • 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 November 6, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 5 mL teaspoonful)

    Chlophedianol Hydrochloride 12.5 mg

    Dexchlorpheniramine Maleate 1 mg

    Pseudoephedrine Hydrochloride 30 mg

  • Purpose

    Cough Suppressant

    Antihistamine

    Nasal Decongestant

  • 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
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    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

    • 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
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes

    Ask a doctor before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • 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 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 every 6 hours, not to exceed 8 teaspoonfuls in 24 hours.
    children 6 to under 12 years of age:1 teaspoonful every 6 hours, not to exceed 4 teaspoonfuls in 24 hours.
    children under 6 years of age:consult a doctor.
  • Other information

    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 or Comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-999-01
    VanaCof®

    Each 5 mL (1 TEASPOONFUL) CONTAINS:
    Chlophedianol Hydrochloride       ….. 12.5 mg
    Dexchlorpheniramine Maleate       ….. 1 mg
    Pseudoephedrine Hydrochloride       ….. 30mg

    PRINCIPAL DISPLAY PANEL
NDC 58809-999-01
VanaCof®

Each 5 mL (1 TEASPOONFUL) CONTAINS:
Chlophedianol Hydrochloride	….. 12.5 mg
Dexchlorpheniramine Maleate	….. 1 mg
Pseudoephedrine Hydrochloride 	….. 30mg

    PRINCIPAL DISPLAY PANEL
NDC 58809-999-01
VanaCof®

Each 5 mL (1 TEASPOONFUL) CONTAINS:
Chlophedianol Hydrochloride	….. 12.5 mg
Dexchlorpheniramine Maleate	….. 1 mg
Pseudoephedrine Hydrochloride 	….. 30mg

  • INGREDIENTS AND APPEARANCE
    VANACOF 
    chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-999
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorTUTTI FRUTTIImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-999-0212 in 1 TRAY04/22/2008
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58809-999-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/22/2008
    Labeler - GM Pharmaceuticals, INC (793000860)