TUSSIN SEVERE MULTI SYMPTOM COUGH COLD PLUS FLU CF MAX (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]

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  • TUSSIN SEVERE MULTI SYMPTOM COUGH COLD PLUS FLU CF MAX (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]

TUSSIN SEVERE MULTI SYMPTOM COUGH COLD PLUS FLU CF MAX (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]
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NDC 11822-0086-1
Set ID d3294a07-f5e6-4d77-9b90-a682265fb609
Category HUMAN OTC DRUG LABEL
Packager Rite Aid Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each 20 mL)

    Acetaminophen, USP 650 mg

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

    Phenylephrine HCl, USP 10 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • 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
  • 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.

  • 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
  • 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
  • Ask a doctor or pharmacist before use if you are

    •
    taking the blood thinning drug warfarin
  • When using this product

    do not use more than directed

  • 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.
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • 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.

  • 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
  • Other information

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

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to the active ingredients of Robitussin® Maximum Strength Severe Multi-Symptom Cough Cold + Flu CF Max

    MAXIMUM STRENGTH

    ADULT

    tussin severe multi-symptom cough cold + flu CF MAX

    acetaminophen, USP 650 mg

    dextromethorphan HBr, USP 20 mg

    guaifenesin, USP 400 mg

    phenylephrine HCl, USP 10 mg

    pain reliever/fever reducer

    cough suppressant

    expectorant

    nasal decongestant

    NON-DROWSY

    ALCOHOL FREE

    relieves:

    cough, sore throat

    body aches, fever

    nasal congestion

    chest congestion

    for ages 12 & over

    8 FL OZ (237 mL)

    tussin severe multi-symptom cough cold + flu CF MAX image
  • INGREDIENTS AND APPEARANCE
    TUSSIN SEVERE MULTI SYMPTOM COUGH COLD PLUS FLU CF MAX 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0086
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (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
    ColorREDScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0086-11 in 1 CARTON09/22/2017
    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 finalpart34109/22/2017
    Labeler - Rite Aid Corporation (014578892)
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