FAMILY CARE COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) LIQUID [UNITED EXCHANGE CORP.]

FAMILY CARE COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) LIQUID [UNITED EXCHANGE CORP.]
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NDC 65923-633-04
Set ID 3bb3a81d-d39a-4f79-84f1-ab0c075d7d34
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL)                                                               Purpose

    Dextromethorphan HBr, USP 20 mg............................................Cough suppressant

    Guaifenesin, USP 200 mg....................................................................Expectorant

  • PURPOSE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain brnchial tubes.
  • WARNINGS

    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 until 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • STOP USE

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    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 mL every 4 hours
     children under 12 years do not use

  • STORAGE AND HANDLING

    Other information

    • each 10 mL contains: sodium 3 mg
    • Store at 20° to 25°C (68° to 77°F). Do not refrigerate.
  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid hydrate, FD&C red no. 40, fruit mixing essence, glycerin, high fructose corn syrup, L-menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE COUGH AND COLD 
    dextromethorphan hydrobromide, and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-633
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE40 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-633-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/29/2015
    Labeler - United Exchange Corp. (840130579)

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