Label: TUSSIN CF COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

  • NDC Code(s): 37012-516-34
  • Packager: Shopko Stores Operating Co., LLC
  • Category: HUMAN OTC DRUG LABEL

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 June 28, 2018

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  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 200 mg

    Phenylephrine HCl, 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 an 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

    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. 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

    10 mL every 4 hours

    children under 12 years

    do not use

  • Other information

    each 10 mL contains: sodium 5 mg
    store at 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare To Robitussin® Multi-Symptom Cold active ingredients

    FOR AGES 12 & OVER

    ADULT

    TUSSIN CF

    COUGH & COLD

    MULTI-SYMPTOM

    Cough Suppressant (Dextromethorphan HBr)

    Expectorant (Guaifenesin)

    Nasal Decongestant (Phenylephrine HCl)

    Relieves:

    Cough

    Nasal Congestion

    Mucus

    Peak Cold

    Non-Drowsy

    Alcohol Free

    CHERRY FLAVOR

    8 FL OZ (237 mL)

    tussin-cf-image
  • INGREDIENTS AND APPEARANCE
    TUSSIN CF  COUGH AND COLD
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-516
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-516-341 in 1 CARTON07/08/2013
    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 finalpart34107/08/2013
    Labeler - Shopko Stores Operating Co., LLC (023252638)