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

  • NDC Code(s): 70000-0133-1, 70000-0133-2
  • Packager: Cardinal Health (Leader) 70000
  • 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 October 6, 2021

If you are a healthcare professional or from the pharmaceutical industry 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
    • 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

    • 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 (1-800-222-1222) right away.

  • Directions

    • do not take more then 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL=milliliter
    • this adult product is not intended for use in children under 12 years of age
    • adults and children 12 years and over: 10 mL every 4 hours
    • children under 12 years: do not use
  • Other information

    • store between 20-25°C (68-77°F). 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

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Adult

    Tussin Multi-Symptom Cold CF

    Dextromethorphan HBr

    Guaifenesin

    Phenylephrine HCI

    Cough Suppressant

    Expectorant

    Nasal Decongestant

    Regular Strength

    Multi-Symptom Cold

    Ages 12 Years and Over

    Relieves:

    Nasal Congestion

    Cough

    Mucus

    Non-Drowsy

    Alcohol Free

    FL OZ (mL)

    Dosing Cup Included

    COMPARE TO ROBITUSSIN® MULTI-SYMPTOM COLD CF active ingredients*

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

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

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313

  • Package Label

    Dextromethorphan HBr 20 mg, Guaifenesin 200 mg, Phenylephrine HCI 10 mg

    LEADER Adult Tussin Multi-Symptom Cold CF

  • INGREDIENTS AND APPEARANCE
    TUSSIN  MULTI SYMPTOM COLD CF
    dextromethorphan hbr, guaifenesin, phenylephrine hci liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0133
    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:70000-0133-11 in 1 BOX01/31/2017
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:70000-0133-21 in 1 BOX01/31/2017
    2237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/31/2017
    Labeler - Cardinal Health (Leader) 70000 (063997360)