COUGH RELIEF NIGHTTIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [FREDS INC]

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COUGH RELIEF NIGHTTIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [FREDS INC]
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NDC 55315-499-12
Set ID 70a8aeaf-528b-4808-88c8-794bc7ccbc0d
Category HUMAN OTC DRUG LABEL
Packager Freds Inc
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
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  • Active ingredients (in each 30 mL)

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purposes

    Cough suppressant

    Antihistamine

  • Uses

    • temporarily relieves cold symptoms
    • cough due to minor throat and bronchial irritation
    • runny nose and sneezing
  • 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 a doctor before use if you have

    • glaucoma
    • cough that occurs with too much phligm (mucus)
    • breathing problems or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    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 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.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not take more than 4 doses in any 24-hours period
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • take only as directed
    • mL = milliliter
    • adults and children 12 years and over: 30 mL every 6 hours
    • children under 12 years of age: do not use

  • Other information

    • each 30 mL contains; sodium 29 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM PST

  • Principal Display Panel

    NIGHTTIME

    Cough Relief 

    Each dose (per 30 mL) of oral solution contains: 

    30 mg-Dextromethorphan HBr- Cough Suppressant

    12.5 mg-Doxylamine Succinate- Antihistamine

    • Sneezing, runny nose
    • cough

    Compare to the active ingredients in Vicks® NyQuil® Cough* 

    Alcohol 10% • Ages 12 +

    FL OZ (mL)

    CHERRY FLAVOR

    *This product is not manufactured or distributed by The Proctor & Gamble Company, Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY: fred's

    4300 NEW GETWELL RD., MEMPHIS, TN 38118

    www.fredsinc.com

  • Product Label

    Dextromethorphan HBr 30 mg, Doxylamine Succinate 12.5 mg

    FRED'S PHARMACY Nighttime Cough Relief

  • INGREDIENTS AND APPEARANCE
    COUGH RELIEF  NIGHTTIME
    dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-499
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-499-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/201804/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/31/201804/26/2024
    Labeler - Freds Inc (005866116)
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