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

  • NDC Code(s): 36800-037-06
  • Packager: TOP CARE (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 15, 2019

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

  • 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

    • for children under 12 years of age
    • 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
    • thyroid disease
    • diabetes
    • high blood pressure
    • 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 fever, 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.

    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 any other dosing device.
    • keep dosing cup with products
    • shake well before using
    • 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 17 mg
    • store between 20-25ºC (68º-77ºF). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX® SEVERE CONGESTION & COUGH ACTIVE INGREDIENTS*

    MAXIMUM STRENGTH

    Mucus Relief

    Severe Congestion and Cough

    DEXTROMETHORPHAN HBr 20 mg COUGH SUPPRESSANT

    GUAIFENESIN 400 mg • EXPECTORANT

    PHENYLEPHRINE HCI 10 mg •  NASAL DECONGESTANT

    MULTI-SYMPTOM RELIEF:

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

    FOR AGES 12 +

    FL OZ (mL)

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

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

    DISTRIBUTED BY TOPCO ASSOCIATED LLC

    ELK GROVE VILLAGE, IL 60007

    topcare@topco.com

  • Package Label

    Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCI 10 mg

    TOPCARE HEALTH Maximum Strength Mucus Relief

  • 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:36800-037
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-037-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/28/2015
    Labeler - TOP CARE (Topco Associates LLC) (006935977)