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

FAMILY CARE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [UNITED EXCHANGE CORP.]
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NDC 65923-629-04
Set ID 85e15203-6d84-4361-877a-7342f070b938
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

    Acetaminophen 650 mg....................................................Pain reliever/fever reducer

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

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

  • PURPOSE

    Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • running nose and sneezing
  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4 doses in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • DO NOT USE

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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 MAOI, ask a doctor or pharmacist before taking this product.
  • ASK DOCTOR

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • cough that occurs with too much 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 a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin
  • WHEN USING

    When using this product

    • excitability 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

    • pain or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occurs
    • cough comes back, or occurs with rash or headache that lasts. 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 our of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • INDICATIONS & USAGE

    Directions

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

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

    children 4 to under 12 yrs: ask a doctor

    children under 4 yrs: do not use

  • STORAGE AND HANDLING

    Other information

    • each 30 mL dose cup contains: potassium 4 mg
    • sodium 33 mg
    • store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredietns

    acesulfame potassium, alcohol, citric acid hydrate, FD&C Green No. 3, FD&C No. 5, glycerin, high fructose corn syrup, L-menthol, methylparaben, mint essence, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium chloride, sodium saccharin

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    Cerritos, CA 90703 U.S.A.

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE COLD AND FLU NIGHTTIME 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-629
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROXYCITRIC ACID (UNII: 8W94T9026R)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-629-04118 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 finalpart34107/21/2015
    Labeler - United Exchange Corp. (840130579)

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