Label: MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • NDC Code(s): 68163-738-09
  • Packager: Raritan Pharmaceuticals Inc
  • 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 September 2, 2023

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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Cough suppressant

    Expectorant

    Nasal Decongestant

  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive  
    •
    temporarily relieves:
    •
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    •
    the intensity of coughing
    •
    the impulse to cough to help you get to sleep
    •
    nasal congestion due to a cold
  • 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
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland 
    •
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    •
    cough that occurs with too much phlegm (mucus)

    ​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 occur with a fever
    •
    cough comes back, or occurs with 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 than 6 doses in a 24-hour period
    •
    measure only with dosing cup provided.
    •
    do not use dosing cup with other products
    •
    dose as follows or as directed by a doctor
    •
    mL=milliliter
    •
    adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
    •
    children under 12 years of age: Do not use
  • Other information

    •
    each 20 mL contains: sodium 8 mg
    •
    low sodium
    •
    store at room temperature
    •
    do not refrigerate
    •
    dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    DRx CHOICE®

    *Compare to the active ingredients Maximum Strength Mucinex® Fast-Max™ Severe Congestion & Cough.

    Maximum Strength

    Mucus Relief

    Severe Congestion and Cough

    Dextromethorphan HBr 20 mg Cough Suppressant

    Guaifenesin - EXPECTORANT

    Phenylephrine HCI - Nasal Decongestant

    •
    Controls Cough
    •
    Relieves Nasal & Chest Congestion
    •
    Thins & Loosens Mucus

    FOR AGES 12 +

    9 FL OZ (266 mL)

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

    PEEL CORNER TO READ COMPLETE DRUG FACTS AND INFORMATION

    ‡Maximum Strength per 4 hour dose.

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court,

    East Brunswick, NJ 08816

    *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough.

    DRx Choice Mucus Relief Severe Congestion and Cough
  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF SEVERE CONGESTION AND COUGH  MAXIMUM STRENGTH
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-738
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-738-09266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/05/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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