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

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NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [FREDS INC]
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NDC 55315-345-12
Set ID 3869d706-4de6-4d8b-9e5f-4f5356b9b581
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
    • runny nose and sneezing
  • Warnings

    Do not use

    • to make a child sleepy
    • 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

    • a sodium-restricted diet
    • asthma
    • emphysema
    • glaucoma
    • excessive phlegm (mucus)
    • breathing problems
    • chronic bronchitis
    • persistent or chronic cough
    • cough associated with smoking
    • 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

    • do not use more than directed
    • 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

    • redness or swelling is present
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • pain or cough gets worse or lasts more than 7 days
    • cough comes back or occurs with rash or headache that lasts

    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
    • mL = milliliter
    agedose 
     adults & children 12 years & over 30 mL every 6 hours
     children 4 to 11 years do not use unless directed by a doctor
     children under 4 years do not use

    • When using DayTime and Nighttime products,carefully read each label to ensure correct dosing
  • Other information

    • each 30 mL contains; sodium 36 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 Vicks® NyQuil® Cough active ingredient* 

    10% ALCOHOL

    AGES 12 & OVER

    FL OZ (mL)

    CHERRY FLAVOR

    *This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Vicks® NyQuil® Cough.

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

    Failure to follow these warnings could result in serious consequences.

    Distributed by: fred's Inc

    4300 New Getwell Rd, Memphis, TN 38118

    www.fredsinc.com

  • Product Label

    Dextromethorphan HBr 30 mg, Doxylamine succinate 12.5 mg

    Fred's Nighttime Cough Relief

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COUGH RELIEF 
    dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-345
    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:55315-345-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/201504/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/31/201504/26/2024
    Labeler - Freds Inc (005866116)
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