Label: TUSSIN CF- dextromethorphan hbr guaifenesin phenylephrine hcl solution

  • NDC Code(s): 70677-1187-1
  • Packager: Strategic Sourcing Services
  • 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 August 17, 2023

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  • Active ingredients (in each 10 mL)


    Dextromethorphan HBrDextromethorphan HBr, USP 20 mg
    Guaifenesin, USP 200 mg
    Phenylephrine HCI, USP 10 mg

  • Purposes

    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses


    ■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    ■ temporarily relieves these symptoms occurring with a cold:
      • nasal congestion
      • cough due to minor throat and bronchial irritation.

  • 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


    ■ heart disease          ■ high blood pressure
    ■ thyroid disease        ■ diabetes
    ■ trouble urinating due to enlarged prostate gland
    ■ cough that occurs with too much phlegm (mucus)
    ■ cough that lasts or is chronic such as occurs with smoking,asthma, chronic bronchitis or emphysema.

  • Ask a doctor or pharmacist before use if you are


    taking any other oral nasal decongestant or stimulant.


    When using this product do not use more than directed.

  • Stop use and ask a doctor if


    ■ you get nervous, dizzy or sleepless
    ■ symptoms do not get better within 7 days or are accompanied by fever
    ■ 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


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


    AGE
    		DOSE
    Adults and children 12 years and over
    		10 mL every 4 hours
    Children under 12 years
    		do not use
  • Other information


    ■ each 10 mL contains: sodium 6 mg
    ■ store at 20-25°C (68-77°F)       ■ do not refrigerate
    ■ Keep carton for full Direction for use

  • Inactive ingredients


    anhydrous citric acid, FD&C red no.40, glycerin, menthol, natural & artificial flavor, propylene glycol,purified water, sodium benzoate, sorbitol solution, sucralose

  • Questions or comments?


    Call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

    ©2023 McKesson Corporation
    Distributed by:McKesson Corp., via Strategic Sourcing Services LLC.
    Memphis, TN 38141
    Money Back Guarantee
    www.fosterandthrive.com

    *This product is not manufactured or distributed by Pfizer,
    owner of the registered trademark Robitussin ®

  • PRINCIPAL DISPLAY PANEL

    Dextromethorphan HBr Guaifenesin Phenylephrone HCL-237 mL

    Dextromethorphan HBr Guaifenesin Phenylephrone HCL-237 mL

  • INGREDIENTS AND APPEARANCE
    TUSSIN CF  
    dextromethorphan hbr guaifenesin phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1187
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1187-11 in 1 CARTON08/09/2023
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/09/2023
    Labeler - Strategic Sourcing Services (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(70677-1187)
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