Label: VIRTUSSIN AC- codeine phosphate and guaifenesin liquid

  • 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 March 2, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

    Codeine phosphate, USP 10 mg

    Cough suppressant

    Guaifenesin, USP 100 mg

    Expectorant
  • Uses

    ▪
    temporarily relieves:
    ▪
    cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    ▪
    your cough to help you sleep
    ▪
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  • Warnings

    Ask your doctor before use if

    ▪
    you have a persistent cough, this may be a sign of a serious condition
    ▪
    you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    ▪
    you have a cough that is accompanied by excessive phlegm (mucus)
    ▪
    you have chronic pulmonary disease or shortness of breath
    ▪
    giving to a child who is taking other drugs

    When using this product

    ▪
    giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
    ▪
    may cause or aggravate constipation

    Stop use and ask a doctor if

    ▪
    symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms 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 6 doses in 24 hours.

    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

    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

    Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

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

    Rev. 07/2019
    7270-0016

  • HOW SUPPLIED

    Product: 50090-5398

    NDC: 50090-5398-0 118 mL in a BOTTLE

  • VIRTUSSIN AC (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID

    Label Image
  • INGREDIENTS AND APPEARANCE
    VIRTUSSIN AC 
    codeine phosphate and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-5398(NDC:69543-252)
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    methylparaben (UNII: A2I8C7HI9T)  
    potassium citrate (UNII: EE90ONI6FF)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    propylparaben (UNII: Z8IX2SC1OH)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-5398-0118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/07/2015
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-5398)
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