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

  • NDC Code(s): 69543-253-04
  • Packager: Virtus Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • 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 January 31, 2019

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

  • Drug Facts

    Active ingredients
    (in each 5 mL = 1 tsp)

    Purpose

    Codeine phosphate, USP 10 mg

    Cough Suppressant

    Guaifenesin, USP 100 mg

    Expectorant

    Pseudoephedrine HCl, USP 30 mg

    Nasal Decongestant

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  • 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
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  • Warnings

    Ask your doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    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
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  • 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
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  • When using this product

    do not use more than directed
    may cause drowsiness
    constipation may occur or be aggravated
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  • 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.
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  • KEEP OUT OF REACH OF CHILDREN


    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.

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  • Directions

    do not exceed 4 doses in any 24 hour period.
     
    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.
     
    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.
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  • 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.

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  • 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.

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Virtus Pharmaceuticals, LLC
    Langhorne, PA 19047
    1-888-848-3593

    Rev. 11/2018
    Made in USA
    7269-0004

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  • Principal Display Panel – 118 mL Bottle Label

    118 mL Bottle Label

    NDC:
    69543-253-04

    Virtussin DAC

    Cough Suppressant
    Expectorant
    Nasal Decongestant

    CV

    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.

    4 fl. oz. (118 mL)

    VIRTUS®
    PHARMACEUTICALS

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  • INGREDIENTS AND APPEARANCE
    VIRTUSSIN DAC 
    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
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69543-253-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/31/2019
    Labeler - Virtus Pharmaceuticals (079659493)
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