Label: AUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution

  • NDC Code(s): 58602-112-18, 58602-112-21
  • Packager: Aurohealth 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 November 13, 2020

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

  • Drug Facts

    Active ingredients (in each 20 mL (4 tsp) dose)

    Dextromethorphan HBr, USP 20 mg
    Guaifenesin, USP 400 mg
    Phenylephrine HCl, USP 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. Avoid foods or beverages that contain caffeine
  • 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 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 right away (1-800-222-1222).

  • Directions

    • 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; tsp = teaspoon
    • Adults and children 12 years and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
    • Children under 12 years of age: do not use unless directed by a doctor
  • Other information

    • Each 20 mL contains: sodium 14 mg
    • Store at 20-25°C (68-77°F)
    • tamper evident: do not use if printed seal under cap is torn or missing
    • do not refrigerate
    • dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

  • Questions or Comments

    1-855-274-4122

    You may also report side effects to this phone number.

    Distributed by:
    Aurohealth LLC.
    2572 Brunswick Pike,
    Lawrenceville, NJ 08648

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

    AUROHEALTH


    NDC 58602-112-18


    Compare to the active ingredients in

    Mucinex® FAST-MAXTM

    Severe Congestion & Cough*


    MAXIMUM STRENGTH**


    AuroMucus

    Fast Maximum

    Severe Congestion & Cough


    Each dose per 20 mL (4 tsp) of oral solution contains:

    20 mg - Dextromethorphan HBr USP (Cough Suppressant)

    400 mg - Guaifenesin USP (Expectorant)

    10 mg - Phenylephrine HCl USP (Nasal Decongestant)


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

    For Ages 12+                         6 FL OZ (177 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 9 FL OZ (266 mL Bottle)

    AUROHEALTH


    NDC 58602-112-21


    Compare to the active ingredients in

    Mucinex® FAST-MAXTM

    Severe Congestion & Cough*


    MAXIMUM STRENGTH**


    AuroMucus

    Fast Maximum

    Severe Congestion & Cough


    Each dose per 20 mL (4 tsp) of oral solution contains:

    20 mg – Dextromethorphan HBr USP (Cough Suppressant)

    400 mg - Guaifenesin USP (Expectorant)

    10 mg - Phenylephrine HCl USP (Nasal Decongestant)


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

    For Ages 12+                         9 FL OZ (266 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 9 FL OZ (266 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    AUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH 
    dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-112
    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)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorBERRY, PINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-112-18177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/18/201506/22/2022
    2NDC:58602-112-21266 mL in 1 BOTTLE; Type 0: Not a Combination Product07/18/201506/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/18/201506/22/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-112)