VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC]

VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC]
PDF | XML

NDC 58809-999-01, 58809-999-02
Set ID cf3886ab-62b3-497a-a587-18cbfbaf3634
Category HUMAN OTC DRUG LABEL
Packager GM Pharmaceuticals, INC
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • 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

    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

  • 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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    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)