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

  • NDC Code(s): 68016-126-04, 68016-126-08
  • Packager: Chain Drug Consortium, LLC
  • 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 December 30, 2020

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

  • Active ingredients

    DRUG FACTS


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

  • Purposes

    Purposes

    Cough Suppressant
    Expectorant
    Nasal Decongestant

  • 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.

  • Uses

    Uses

    • help 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 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 Ask a doctor or pharmacist before use

    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

    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

    If pregnant or breast feeding,

    ask a health professional before use.

  • Directions

    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 and children 12               2 teaspoons every 4 hours
    years and over

    children under 12                      do not use

  • Other information

    Other information

    • Keep carton for full Direction for use.
    • store at 20‐25 ° C (68‐77 ° F)
    • do not refrigerate
    • dosage cup provided
    • sodium 3 mg per teaspoonful
  • Inactive ingredients

    Inactive ingredients

    anhydrous citric acid, FD and C red no. 40, glycerin, menthol, natural and 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

    NDC 68016-126-04

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


    Premier Value ®
    Tussin CF


    Dextromethorphan HBr/ Guaifenesin / Phenylephrine HCL

    COUGH SUPPRESSANT
    EXPECTORANT/
    NASAL DECONGESTANT

    NON-DROWSY

    Multi-Symptom Formula

    For ages 12 and over
    8 FL OZ (237 mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED   PV
    If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

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

    DISTRIBUTED BY: CHAIN DRUG CONSORTIUM 3301 NW BOCA RATON BLVD SUITE 101, BOCA RATON, FL 33431
    BX-018
    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    AptaPharma Tussin CF2 Label


  • INGREDIENTS AND APPEARANCE
    TUSSIN CF  
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-126
    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 (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-126-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2012
    2NDC:68016-126-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/15/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-126)