VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [UNIT DOSE SERVICES]

  • Home
  • VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [UNIT DOSE SERVICES]

VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [UNIT DOSE SERVICES]
PDF | XML
NDC 50436-2520-1
Set ID 2ba017d3-1d82-4215-8820-711705540fa4
Category HUMAN OTC DRUG LABEL
Packager Unit Dose Services
Generic Name
Product Class
Product Number
Application Number PART341
View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL = 1 tsp)Purpose
    Codeine phosphate, USP 10 mgAntitussive
    Guaifenesin, USP 100 mgExpectorant
  • 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.

  • HOW SUPPLIED

    Product: 50436-2520

    NDC: 50436-2520-1 118 mL in a BOTTLE

  • VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID

    Label Image
  • INGREDIENTS AND APPEARANCE
    VIRTUSSIN A/C 
    codeine phosphate and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-2520(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:50436-2520-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/07/2015
    Labeler - Unit Dose Services (831995316)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unit Dose Services831995316REPACK(50436-2520) , RELABEL(50436-2520)
View All Sections

Related Drugs

Search DailyMed Drugs