Label: TUSSIN CF ADULT MULTI SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • 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 November 20, 2019

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

  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 200 mg

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

    When using this product,

    do not use more than directed.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • 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.

  • Directions

    • shake well before using
    • 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
    • adult and children 12 years and over: 10mL every 4 hours
    • children under 12 years do not use
  • Other information

    • store at 20-25ºC (68-77ºF). Do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, FD&C red 40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

  • Principal Display Panel

    *Compare to active ingredients in Robitussin® Peak Cold Multi-Symptom Cold CF

    Adult

    Tussin CF

    Multi-Symptom Cold

    Dextromethorphan HBr

    (Cough suppressant)

    Guaifenesin

    (Expectorant)

    Phenylephrine HCl

    (Nasal decongestant)

    For Relief of:

    • Cough
    • Chest Congestion
    • Stuffy Nose

    For ages 12 & over

    Alcohol free

    non-drowsy

    FL OZ (mL)

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Robitussin® Peak Cold Multi-Symptom Cold CF.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

    Distributed by:

    Marc Glassman, Inc.

    West 130th Street

    Cleaveland, OH 44130

  • Package Label

    Dextromethorphan HBr 20mg Guaifenesin 200mg Phenylephrine HCI 10mg

    Marc's Tussin CF Multi-Symptom Cold

  • INGREDIENTS AND APPEARANCE
    TUSSIN CF  ADULT MULTI SYMPTOM COLD
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-382
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MENTHOL (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-382-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/201412/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/30/201412/30/2021
    Labeler - Marc Glassman, Inc. (094487477)