RUGBY COUGH GUAIFENESIN (GUAIFENESIN) LIQUID [UNIT DOSE SERVICES]

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RUGBY COUGH GUAIFENESIN (GUAIFENESIN) LIQUID [UNIT DOSE SERVICES]
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NDC 50436-1095-1
Set ID 7486c5ae-3e00-4c9f-bcb7-047a90af0f94
Category HUMAN OTC DRUG LABEL
Packager Unit Dose Services
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 10 mL)

    Guaifenesin, USP 200 mg

  • Purpose

    Expectorant

  • Uses

    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 last more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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 at 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
    agedose

    adults and children 12 years and over

    10 mL-20 mL every 4 hours

    children under 12 years

    do not use
  • Other information

    •
    each 10 mL contains:sodium 4 mg
    •
    store at 20-25°C (68-77°F).
    •
    alcohol-free
  • Inactive ingredients

    citric acid, disodium edetate , FD&C red no. 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • Questions?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI 48150

    www.rugbylaboratories.com

    Re-order No.370448

    Rev.10/15

    R-107

  • HOW SUPPLIED

    Product: 50436-1095

    NDC: 50436-1095-1 1 mL in a CARTON / 118 in a BOTTLE

  • RUGBY COUGH SYRUP GUAIFENESIN (GUAIFENESIN) LIQUID

    Label Image
  • INGREDIENTS AND APPEARANCE
    RUGBY COUGH GUAIFENESIN 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-1095(NDC:0536-1095)
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50436-1095-1118 in 1 BOTTLE01/08/2019
    11 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/20/2016
    Labeler - Unit Dose Services (831995316)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unit Dose Services831995316REPACK(50436-1095) , RELABEL(50436-1095)
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