ADULT TUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [MARC GLASSMAN, INC.]

ADULT TUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [MARC GLASSMAN, INC.]
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NDC 68998-528-20
Set ID 3b81d6be-7014-4d9a-80ff-3296fd0478a4
Category Human OTC Drug Label
Packager Marc Glassman, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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
  • 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

    • do not take more than 6 doses (12 tsp) 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 6 mg
    • store at 20-25°C (68-77°F). Do not refrigerate
    • see bottom panel for lot number and expiration date 
  • Inactive ingredients

    anhydrous citric acid, FD & C Red No. 40 powder, glycerin, menthol, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

  • QUESTIONS

    Distributed by:
    Marc Glassman, Inc.
    West 130th Street
    Cleveland, OH 44130

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (237 mL Bottle) Label

    NDC 68998-528-20

    Compare to the active ingredients in
    Adult Robitussin® Peak Cold
    Muti-Symptom Cold

    Marcs®
    adult
    Tussin CF
    MULTI-SYMPTOM COLD

    Dextromethorphan HBr
    (Cough Suppressant)
    Guaifenesin
    (Expectorant)
    Phenylephrine HCl
    (Nasal Decongestant)

    For Relief of:

     

    • Cough
    • Nasal Congestion
    • Mucus
    • For Ages 12 & Over
    • Non-Drowsy                               
    • Berry Flavor

     

    8 FL OZ (237 mL)   

    fi1

  • INGREDIENTS AND APPEARANCE
    ADULT TUSSIN CF MULTI-SYMPTOM COLD 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-528
    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)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BERRY (UNII: FV3431923Z)  
    Product Characteristics
    ColorRED (a clear red colored liquid) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-528-201 in 1 CARTON07/14/2017
    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 FINALpart34107/14/2017
    Labeler - Marc Glassman, Inc. (094487477)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(68998-528)

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