Label: MUCOSAN SEVERE MULTI-SYMPTOM- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • NDC Code(s): 53145-697-06
  • Packager: Menper Distributors, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 11, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL) Purpose

    Dextromethorphan HBr, 20 mg...........................Cough suppressant

    Guaifenesin, 400 mg..........................................Expectorant

    Phenylephrine HCl, 10 mg.................................Nasal decongestant

  • PURPOSE

    Purposes

    Cough suppressant

    Expectorant

    Nasal descongestant

  • INDICATIONS & USAGE

    Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occuring with a cold:
    • nasal congestion
    • cough due to minor throat and bronquial irritation.
  • WARNINGS

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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 DOCTOR

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

  • OVERDOSAGE

    Do not exceed recommended dosage.

  • STOP USE

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health prefessional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 6 doses in any 24 hour period
    • this adult strenght product is not intended for use in children under 12 years of age
    • measure only wih doisng cup provided
    • keep dosing cup with product
    • mL=milliliter

    agedose
    adults and children 12 years of age and older20 mL every 4 hours
    children under 1 years of agedo not use

  • OTHER SAFETY INFORMATION

    Other information

    • each (20mL) dose contains: sodium 10 mg
    • store between 15-30°C (59-86°F)
    • do not refrigerate.
  • INACTIVE INGREDIENT

    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, xanthan gum.

  • QUESTIONS

    Questions or comments?

    1-800-560-5223 Monday to Friday 9am-4pm, Eastern Time

  • PRINCIPAL DISPLAY PANEL

    MUCOSAN SEVERE LABELMUCOSAN SEVERE BOX

  • INGREDIENTS AND APPEARANCE
    MUCOSAN SEVERE MULTI-SYMPTOM 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-697
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 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
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-697-061 in 1 CARTON11/01/2024
    1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/01/2024
    Labeler - Menper Distributors, Inc. (101947166)
    Registrant - Menper Distributors, Inc. (101947166)