FAMILY CARE COUGH NIGHTTIME (DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [UNITED EXCHANGE CORP.]

FAMILY CARE COUGH NIGHTTIME (DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [UNITED EXCHANGE CORP.]
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NDC 65923-625-04
Set ID a43ec952-6841-4729-aded-9a7affe9d411
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each 30 mL dose cup)                             Purpose

    Dextromethorphan HBr 30 mg................................Cough suppressant

    Doxylamine succinate 12.5 mg.......................................Antihistamine

  • PURPOSE

    Uses temporarily relieves cold symptoms: 

    • cough due to minor throat and bronchial irritation
    • runny nose and sneezing

  • 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 for 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

    • glaucoma
    • cough that occurs with excessive phlegm (mucus)
    • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to enlarged prostate gland
    • a sodium-restricted diet
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

  • WHEN USING

    When using this product

    • excistability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness
  • STOP USE

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. A persistent cough may be a sign 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

    • take only as directed
    • use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hrs

    adults & children 12 years over: 30 mL (2 TBSP) every 6 hrs

    children 4 to under 12 years: ask a doctor

    children under 4 years: do not use

  • STORAGE AND HANDLING

    Other information

    • each 30 mL dose cup contains: sodium 7 mg
    • store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, cherry essence, citric acid hydrate, FD&C Blue No. 1, FD&C Red No. 40, glycerin, high fructose corn syrup, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium saccharin, xanthan gum

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE COUGH NIGHTTIME 
    dextromethorphan hydrobromide, and doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-625
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-625-04118 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 finalpart34107/20/2015
    Labeler - United Exchange Corp. (840130579)