TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CONSUMER VALUE PRODUCTS, INC.]

TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CONSUMER VALUE PRODUCTS, INC.]
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NDC 57243-504-24
Set ID 6b0dd40b-094e-476e-b944-ac7f29d707bd
Category HUMAN OTC DRUG LABEL
Packager Consumer Value Products, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

  • PURPOSE

    Purpose
    Dextromethorphan HBr...........................Cough Suppressant
    Guaifenesin ..........................................Expectorant
    Phenylephrine HCl .................................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, 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 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 if you are taking any other oral nasal
    decongestant or stimulant.

  • STOP USE

    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, or is accompanied
    by fever, rash or persistent headache.
    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask ahealth professilfial before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose,
    get medical help or contact a Poison 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                      do not use

  • OTHER SAFETY INFORMATION

    Other information
    ■Keep carton for full Directions for use.
    ■ store at 20-25°C (68-77°F)
    ■ do not refrigerate
    ■ dosage cup provided
    ■ sodium 3 mg per teaspoonful

  • INACTIVE INGREDIENT

    Inactive ingredientsanhydrous 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

  • Principal Display Panel

                   CVP®
                 HEALTH

                TUSSIN
                    CF

    COUGH & CHEST CONGESTION

              NON-DROWSY

       COUGH SUPPRESSANT

             EXPECTORANT

      NASAL DECONGESTANT

         COMPARE TO THE ACTIVE INGREDIENTS IN
    ROBITUSSIN® PEAK COLD MULTI-SYMPTOM COLD®

                   CVP®
                HEALTH

               TUSSIN
                   CF

           COUGH & CHEST
             CONGESTION

     DEXTROMETHORPHAN HBr/
    GUAIFENESIN/PHENYLEPHRINE HCl

                NON-DROWSY
          COUGH SUPPRESSANT
               EXPECTORANT
        NASAL DECONGESTANT

    RELIEVES

    • COUGH
    • MUCUS
    • NASAL CONGESTION

    FOR AGES 12 AND OVER

    4 FL OZ (118 mL)

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

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

    DISTRIBUTED BY
    CONSUMER VALUE PRODUCTS, INC.
    P.O. BOX 6115 TEMPLE, TX 76502
    CVPproducts.com

    7   61706 16125   8

                                       BX-074

    TussinCF 504 4OZ Box

    ↓ Bottle Label ↓

    TussinCF 504 4OZ Botle

         TUSSIN CF by Consumer Value Products, Inc.  

    res

  • INGREDIENTS AND APPEARANCE
    TUSSIN CF 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-504
    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) PHENYLEPHRINE5 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 (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57243-504-241 in 1 CARTON10/01/2018
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2018
    Labeler - Consumer Value Products, Inc. (009830555)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(57243-504)

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