FAMILY CARE MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [UNITED EXCHANGE CORP.]

FAMILY CARE MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [UNITED EXCHANGE CORP.]
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NDC 65923-632-04
Set ID 5f02745f-0197-4c58-9b46-92b8aa78bf3b
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredient (in each 10 mL)                                                 Purpose

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

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

    Phenylephrine HCI, USP 10 mg....................................Nasal decongestant

  • PURPOSE

    Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occuring with a cold
    • nasal congestion
    • cough due to minor throat and bronchial irritation.
  • 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 or pharmacist before us if you are taking any other oral nasal decongestant or stimulant.

  • WHEN USING

    When using this product do not use more than directed.

  • STOP USE

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • 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 2 mg
    • store at 20° to 25°C (68° to 77°F)
    • Do not refrigerate
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    Distribued by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 U.S.A

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE MULTI SYMPTOM COLD 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-632
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-632-04118 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 finalpart34107/31/2015
    Labeler - United Exchange Corp. (840130579)

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