EXTRA ACTION COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RPK PHARMACEUTICALS, INC.]

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EXTRA ACTION COUGH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RPK PHARMACEUTICALS, INC.]
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NDC 53002-4610-1
Set ID 719c5d49-66c3-4a71-abb7-b1f775a87965
Category HUMAN OTC DRUG LABEL
Packager RPK Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each teaspoonful [TSP]) Purposes
    Dextromethorphan HBr USP 10 mgAntitussive
    Guaifenesin USP 100 mgExpectorant
  • Uses

    • temporarily quiets cough caused by the common cold or inhaled irritants
    • helps loosen phlegm and thin bronchial secretions to make coughs more productive
  • Warnings

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before use.

    Ask a doctor before use if you have

    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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.

  • Directions

    • take every 4 hours
    • do not take more than 6 doses in 24 hours
    • use only with enclosed dose cup. Do not use with any other device.
    adults and children 12 years and over2 TSP
    children 6 to under 12 years1 TSP
    children under 6 yearsdo not use
  • Other information

    • each TSP contains: sodium 3 mg
    • store at room temperature 15°-30° C (59°-86°F)
  • Inactive ingredients

    Artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, purified water, sodium benzoate, sodium saccharin

  • Questions or comments?

    call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

    Extra Action Cough Syrup is distributed by Rugby Laboratories, Inc.
    Duluth, Georgia 30097

  • HOW SUPPLIED

    Product: 53002-4610

    NDC: 53002-4610-1 118 mL in a BOTTLE

  • Guiatuss DM Syrup

    Label Image
  • INGREDIENTS AND APPEARANCE
    EXTRA ACTION COUGH 
    guaifenesin and dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53002-4610(NDC:0536-0970)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Corn Syrup (UNII: 9G5L16BK6N)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Cherry (UNII: BUC5I9595W)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorPINK (Reddish-Pink) Score    
    ShapeSize
    FlavorMENTHOL, CHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53002-4610-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/03/2011
    Labeler - RPK Pharmaceuticals, Inc. (147096275)
    Establishment
    NameAddressID/FEIBusiness Operations
    RPK Pharmaceuticals, Inc.147096275RELABEL(53002-4610)
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