Label: FAMILY CARE COUGH NIGHTTIME- dextromethorphan hydrobromide, and doxylamine succinate liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 20, 2015

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  • 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)