Label: TOPCO TUSSIN CF MAX- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

  • NDC Code(s): 36800-707-26, 36800-707-34
  • Packager: Topco Associates 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 October 26, 2017

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

  • Active ingredients (in each 20 mL)

    Acetaminophen, USP 650 mg

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

    Phenylephrine HCl, USP 10 mg

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  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

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  • Uses

    temporarily relieves these symptoms occurring with a cold or flu:
    cough due to minor throat and bronchial irritation
    nasal congestion
    sinus congestion and pressure
    minor aches and pains
    sore throat
    headache
    temporarily reduces fever
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
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  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    more than 4,000 mg of acetaminophen in 24 hours
    with other drugs containing acetaminophen
    3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    skin reddening
    blisters
    rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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  • 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.
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    if you have ever had an allergic reaction to this product or any of its ingredients
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  • Ask a doctor before use if you have

    liver disease
    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged prostate gland
    cough that occurs with too much phlegm (mucus)
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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  • Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin
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  • When using this product

    do not use more than directed

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  • Stop use and ask a doctor if

    you get nervous, dizzy or sleepless
    pain, cough, or nasal congestion gets worse or lasts more than 7 days
    fever gets worse or lasts more than 3 days
    redness or swelling is present
    new symptoms occur
    cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    do not take more than 5 doses in any 24-hour period
    do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
    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

    20 mL every 4 hours

    children under 12 years

    do not use

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  • Other information

    each 20 mL contains: sodium 15 mg
    store at 20-25 °C (68-77 °F). Do not refrigerate.
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  • Inactive ingredients

    anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C red #40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triacetin, xanthan gum

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  • Questions or comments?

    1-888-423-0139

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  • Package/Label Principal Display Panel

    FOR ADULTS

    For Ages 12 & Over

    Tussin

    CF Max

    PAIN RELIEVER/FEVER REDUCER

    (Acetaminophen)

    COUGH SUPPRESSANT

    (Dextromethorphan HBr)

    EXPECTORANT

    (Guaifenesin)

    NASAL DECONGESTANT

    (Phenylephrine HCl)

    SEVERE

    Multi-Symptom

    Cough Cold + Flu

    Maximum Strength

    Non-Drowsy

    Relieves:

    Cough, Sore Throat

    Body Aches, Fever

    Nasal Congestion

    Chest Congestion

    QUALITY GUARANTEED

    COMPARE TO ROBITUSSIN® SEVERE MULTI-SYMPTOM COUGH COLD + FLU active ingredients

    4 FL OZ (118 mL)

    tussin cf max image 1
    tussin cf max image 2
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  • INGREDIENTS AND APPEARANCE
    TOPCO TUSSIN CF MAX 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-707
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 20 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-707-26 1 in 1 CARTON 09/11/2017
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:36800-707-34 1 in 1 CARTON 09/14/2017
    2 237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/11/2017
    Labeler - Topco Associates LLC (006935977)
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