Label: ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE- dextromethorphan hbr, guaifenesin liquid

  • NDC Code(s): 71399-1006-4, 71399-1006-6, 71399-1006-8
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 11, 2022

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  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 200 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 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 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
    • adults and children 12 years and over: 10 mL every 4 hours
    • children under 12 years: do not use
  • Other information

    • Phenylketonurics: contains Phenylalanine 30 mg per 10 mL
    • store between 20-25ºC(68-77ºF). Do not refrigerate
  • Inactive ingredients

    acesulfame potassium, citric acid, flavor cherry, glycerin, menthol crystals, purified water, sorbitol solution 70%, sodium citrate, sodium saccharin, sodium benzoate.

  • Questions or comments?

    toll-free 1-877-225-6999

  • PRINCIPAL DISPLAY PANEL

    4oz

    8oz

    16oz

  • INGREDIENTS AND APPEARANCE
    ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-1006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Colorwhite (colorless) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-1006-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2022
    2NDC:71399-1006-8236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2022
    3NDC:71399-1006-6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/11/2022
    Labeler - Akron Pharma Inc. (067878881)
    Registrant - SLV PHARMACEUTICALS LLC (081225162)
    Establishment
    NameAddressID/FEIBusiness Operations
    SLV PHARMACEUTICALS LLC081225162manufacture(71399-1006)
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