VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]

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VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]
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NDC 69543-252-04, 69543-252-16
Set ID 718f699a-c5eb-4e2b-b43e-45525ecf6502
Category HUMAN OTC DRUG LABEL
Packager Virtus Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART341
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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 Product07/07/2015
    2NDC:69543-252-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/07/2015
    Labeler - Virtus Pharmaceuticals (079659493)
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