TUSSIN COUGH AND CHEST CONGESTION DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [RITE AID CORPORATION]

TUSSIN COUGH AND CHEST CONGESTION DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [RITE AID CORPORATION]
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NDC 11822-1200-1, 11822-1200-2
Set ID 0faee5a8-8aef-4dfb-a435-90bb3ab2e340
Category HUMAN OTC DRUG LABEL
Packager Rite Aid Corporation
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • 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

    cough that occurs with too much phlegm (mucus)
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Stop use and ask a doctor if

    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 right away (1-800-222-1222).

  • Directions

    do not take more than 6 doses in any 24-hour period
    measure only with dosing cup provided
    keep dosing cup with product
    mL = milliliter
    this adult product is not intended for use in children under 12 years of age

    age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use

  • Other information

    each 20 mL contains: sodium 13 mg
    store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    acetic acid, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    SEE NEW DOSING

    Compare to the active ingredients of Robitussin® Maximum Strength Cough + Chest Congestion DM

    MAXIMUM STRENGTH

    ADULT

    tussin

    cough & chest

    congestion DM

    MAX

    dextromethorphan HBr, USP 20 mg

    guaifenesin, USP 400 mg

    cough suppressant

    expectorant

    NON-DROWSY

    ALCOHOL FREE

    relieves:

    cough

    mucus

    for ages 12 & over

    4 FL OZ (118 mL)

    2B783-tussin-cough-chest-congestion-dm-max.jpg
  • INGREDIENTS AND APPEARANCE
    TUSSIN COUGH AND CHEST CONGESTION DM MAX 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1200-11 in 1 CARTON08/02/2018
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11822-1200-21 in 1 CARTON08/02/2018
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/02/2018
    Labeler - Rite Aid Corporation (014578892)

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