TUSSIN DM NIGHTTIME COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WINCO FOODS, LLC]

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TUSSIN DM NIGHTTIME COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WINCO FOODS, LLC]
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NDC 67091-333-18
Set ID 410ddcb2-dde1-45e3-bb35-d3e4ce75c1f5
Category HUMAN OTC DRUG LABEL
Packager WinCo Foods, LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purposes

    Cough suppressant

    Antihistamine

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • controls the impulse to cough to help you sleep
  • Warnings

    Do not use

    • to sedate a child or 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

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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • do not use more than directed
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur especially in children

    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

    • this adult product is not intended for use in children under 12 years of age
    • do not take more than 4 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • adults and children 12 years and over: 20 mL every 6 hours
    • children under 12 years: do not use

  • Other information

    • each 20 mL contains: sodium 9 mL
    • store between 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, carboxymethycellulose sodium, FD&C blue #1, FD&C red #40, flavors glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

  • Questions or comments?

    Call 1-800-824-1706 Monday-Friday 9AM-5PM MST

  • Principal Display Panel

    *Compare to the active ingredients in Robitussin® Maximum Strength Nighttime Cough DM

    MAXIMUM STRENGTH

    Tussin DM

    Nighttime 

    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

    DOXYLAMINE SUCCINATE / ANTIHISTAMINE

    Relieves: Cough, Itchy Throat & Runny Nose

    Adult Formula, For Ages 12 Years & Over

    Alcohol Free

    Dosage cup provided

    FL OZ (mL)

    *This product is not manufactured or distributed by PFIZER CONSUMER HEALTHCARE, distributors of RONITUSSIN® Maximum Strength Nighttime Cough DM.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY:

    WINCO FOODS, LLC, BOISE, ID 83704

  • Package Label

    Dextromethorphan HBr 30 mg,Doxylamine Succinate 12.5 mg

    WINCO FOODS Maximum Strength Nighttime Cough

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM NIGHTTIME COUGH  MAXIMUM STRENGTH
    dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 20 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-333-181 in 1 BOX02/01/201905/31/2024
    1118 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 finalpart34102/01/201905/31/2024
    Labeler - WinCo Foods, LLC (056098817)
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