Label: VIRTUSSIN DAC- codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquid

  • NDC Code(s): 69543-253-16
  • Packager: Virtus Pharmaceuticals
  • DEA Schedule: CV
  • 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 March 8, 2019

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    Drug Facts


    Active ingredients (in each 5 mL = 1 tsp) Purpose

    Codeine phosphate, USP 10 mg

    Cough Suppressant

    Guaifenesin, USP 100 mg


    Pseudoephedrine HCl, USP 30 mg

    Nasal Decongestant

  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    temporarily relieves nasal congestion due to the common cold
    temporarily restores freer breathing through the nose
    helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    calms the cough control center and relieves coughing
  • Warnings

    Ask your doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    trouble urinating due to enlarged prostate gland
    cough that occurs with excessive phlegm (mucus)
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Do not use

    in a child under 2 years of age
    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.
    if you or your child has a chronic pulmonary disease or shortness of breath
    if your child is taking other drugs, unless directed by a doctor

    When using this product

    do not use more than directed
    may cause drowsiness
    constipation may occur or be aggravated

    Stop use and ask a doctor if

    you get nervous, dizzy, or have trouble sleeping
    cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    do not exceed 4 doses in any 24 hour period.
    Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

    Adults and children 12 years of age and over:

    2 tsp (10 mL) every 4 hours, or as directed by a doctor.

    Children 6 to under 12 years of age:

    1 tsp (5 mL) every 4 hours, or as directed by a doctor.

    Children under 6 years of age:

    Consult a doctor.

  • Other information

    Each tsp (5 mL) contains 3 mg sodium.

    Store at controlled room temperature 15°-30°C (59°-86°F).

    You may report side effects by calling 1-888-848-3593 or FDA at 1-800-FDA-1088.

  • Inactive ingredients

    Alcohol, caramel flavor, cherry flavor, citric acid, FD&C red #40, glycerin, menthol flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol 70% solution.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label


    NDC: 69543-253-16


    Cough Suppressant
    Nasal Decongestant


    SUGAR FREE • 2.1% (v/v) ALCOHOL

    Each 5 mL (1 teaspoonful) contains:
    Codeine phosphate, USP    10 mg
    Guaifenesin, USP    100 mg
    Pseudoephedrine HCl, USP    30 mg
    (WARNING: May be habit-forming)

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

    16 fl. oz. (473 mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
    codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69543-253
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Codeine phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J) Codeine phosphate 10 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg  in 5 mL
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol (UNII: 3K9958V90M)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    potassium citrate (UNII: EE90ONI6FF)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CARAMEL, CHERRY, MENTHOL Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69543-253-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2015 03/31/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/25/2015 03/31/2020
    Labeler - Virtus Pharmaceuticals (079659493)