Label: TUSSIN CF- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts


    Active ingredients
    (in each 5 mL tsp)
    Dextromethorphan HBr, USP 10 mg
    Guaifenesin, USP 100 mg
    Phenylephrine HCL, USP 5 mg

  • PURPOSE

    Purpose
    Dextromethorphan HBr USP ........Cough Suppressant
    Guailenesin USP ..........................Expectorant
    Phenylephrine HCI, USP ...............Nasal Decongestant

  • INDICATIONS & USAGE

    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

    Warnings
    Do not use ■ if you are now taking aprescription
    monoamine oxidase inhibitor (MAOI) (certain drugs
    for depression, psychialric or emotional conditions or
    Parkinson's disease), or for 2 weeks aMer stopping
    the MAOI drug. If you do not know il your
    prescription drug contains an MAOI, ask a doctor or
    pharmacist before taking this product.

  • ASK DOCTOR

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use il you are
    taking any other oral nasal decongestant or stimulant.

  • WHEN USING

    When using this product do not use more than
    directed.

  • STOP USE

    Stop use and ask a doctor if
    ■ you get nervous, diuy 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 ot aserious
       condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose,
    get medical help or contact aPoison Control Center
    right away.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ 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

               AGE              DOSE

     Adults & children 12

         years & over

     2 teaspoons every 4 hours
     Children under 12 years 2 teaspoons every 4 hours

  • OTHER SAFETY INFORMATION

    Other information
    ■ Keep carton for full Direction for use
    ■ store at 20-25ºC (68-77ºF)
    ■ do not refrigerate
    ■ dosage cup provided
    ■ sodium 3 mg per teaspoonful

  • INACTIVE INGREDIENT

    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

    Questions? Call weekdays from 9:30 AM to 4:30
    PM EST at 1-877·798-5944

  • Product Label

    AP SAFE                         NDC 76821-504-24

    COMPARE TO THE ACTIVE

    INGREDIENT IN ROBITUSSIN®

    PEAK COLD

    MULTI-SYMPTOM COLD*

    Adult Tussin

    Multi-Symptom Cold

    Dextromethorphan HBr / Guaifensesin /

    Phenylephrine HCL

    Cough Supressant / Expectorant /

    Nasal Decongestant

    Non-Drowsy

    Relieves:
    • Cough
    • Mucus
    • Nasal Congestion
    • For Ages 12 and over

    4 FL OZ (118 mL)

    CF

    DO NOT USE IF PRINTED SEAL UNDER
    CAP IS TORN OR MISSING

    5
    1013430
    3/20

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

    Manufactured by:
    AptaPharma Inc.,
    1533 Union Ave,
    Pennsauken, NJ 08110

    Ap·BX·05

    Carton

    504 TussinCF 4 OZ Box

    Bottle

    504 TussinCF 4 OZ Btl

    res

  • INGREDIENTS AND APPEARANCE
    TUSSIN CF 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 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)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-504-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/30/2020
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-504)