SUNMARK TUSSIN (GUAIFENESIN) SOLUTION [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]

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SUNMARK TUSSIN (GUAIFENESIN) SOLUTION [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]
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NDC 76413-328-01
Set ID 7b1492ef-c8ab-4776-97b1-5982d2ea69a0
Category HUMAN OTC DRUG LABEL
Packager Central Texas Community Health Centers
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient (in each 10 mL)

    Guaifenesin, USP 200 mg

  • Purpose

    Expectorant

  • Use

    helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

  • Warnings

  • Ask a doctor before use if you have

    •
    cough that occurs with too much phlegm (mucus)
    •
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Stop use and ask a doctor if

    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosing cup provided
    •
    keep dosing cup with product
    •
    mL = milliliter
    •
    this adult product is not intended for use in children under 12 years of age

    age

    dose

    adults and children 12 years and over

    10 – 20 mL every 4 hours

    children under 12 years

    do not use
  • Other information

    •
    store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, caramel, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, maltol, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

  • Questions or comments?

    1-800-719-9260

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton Label

    CommUnityCare Federally Qualified Health Centers

    TUSSIN
    118ml

    Date:

    Dr.

    Name:

    TAKE AS DIRECTED.

    123456

    1/1/01

    TUSSIN 118ml NDC 76413-328-01
    Batch: 123456
    Lot: 123456
    Exp: 1/1/01
    SUNMARK
    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton Label
  • INGREDIENTS AND APPEARANCE
    SUNMARK TUSSIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-328(NDC:49348-135)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MALTOL (UNII: 3A9RD92BS4)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorRED (dark) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76413-328-011 in 1 CARTON09/17/2014
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/17/2014
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK(76413-328) , RELABEL(76413-328)
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