Label: VIRTUSSIN AC- codeine phosphate and guaifenesin liquid

  • NDC Code(s): 69543-252-04, 69543-252-16
  • 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 August 17, 2022

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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

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC: 69543-252-16

    Virtussin
    AC

    Cough Suppressant
    Expectorant

    CV

    SUGAR FREE • DYE FREE
    ALCOHOL FREE

    Each 5 mL (1 teaspoonful) contains:
    Codeine phosphate, USP . . . 10 mg
    Guaifenesin, USP . . . . . . . 100 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)

    VIRTUS®
    PHARMACEUTICALS

    473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    VIRTUSSIN AC 
    codeine phosphate and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:69543-252-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/201510/31/2022
    2NDC:69543-252-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/201503/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/07/201503/31/2023
    Labeler - Virtus Pharmaceuticals (079659493)
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