Label: VANACOF CP ALLERGY / COUGH- chlophedianol hcl, pyrilamine maleate solution

  • NDC Code(s): 58809-189-08
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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

    Chlophedianol HCl 12.5 mg

    Pyrilamine Maleate 25 mg

  • Purpose

    Cough Suppressant

    Antihistamine

  • Uses

    ■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies:
    ■ runny nose ■ itching of the nose or throat
    ■ sneezing ■ 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
    ■ glaucoma
    ■ difficulty in urination due to enlargement of the prostate gland
    ■ a cough that occurs with too much phlegm (mucus)
    ■ a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor before use if you are

    taking sedatives or tranquilizers

    When using this product

    ■ do not use more than directed ■ avoid alcoholic drinks
    ■ marked drowsiness may occur
    ■ alcohol, sedatives, and tranquilizers may increase drowsiness
    ■ be careful when driving a motor vehicle or operating machinery
    ■ excitability may occur, especially in children

    Stop use and ask a doctor if

    • ■ nervousness, dizziness, or sleeplessness occurs
    • ■ symptoms do not improve within 7 days, tend to recur, or are 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 take more than 4 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:30 mL (2 TBSP) every 6 to 8 hours, not to exceed 120 mL (8 TBSP) per 24 hours
    children 6 to under 12 years of age:15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) per 24 hours
    children under 6 years:consult a doctor.

  • Other information

    ■ store at 20° to 30°C (68° to 86°F)
    ■ each 15 mL (1 TBSP) contains: Sodium 8.5 mg

  • Inactive ingredients

    citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

  • Questions?

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

  • OTHER SAFETY INFORMATION

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

  • SPL UNCLASSIFIED SECTION

    U.S. Pat: 9,463,191

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

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-189-08

    VANACOF ® CP

    Allergy / Cough

    Each 15 mL (1 TBSP) contains:

    Chlophedianol HCl .................... 12.5 mg

    Pyrilamine Maleate ....................... 25 mg

    Cough Suppressant • Antihistamine

    Alcohol Free / Sugar Free / Gluten Free / Dye Free

    GM Pharmaceuticals, Inc.

    8 fl oz (237 mL)

    VanaCof CP

  • INGREDIENTS AND APPEARANCE
    VANACOF CP ALLERGY / COUGH 
    chlophedianol hcl, pyrilamine maleate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-189
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 15 mL
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE25 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-189-08237 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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