Label: NIVANEX DMX- guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet

  • 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 February 14, 2022

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each Tablet)Purpose
    Dextromethorphan HBr 15 mgCough Suppressant
    Guaifenesin 380 mgExpectorant
    Phenylephrine HCl 10 mgNasal Decongestant
  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • nasal congestion
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • 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

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

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
    • new symptoms occur

    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.

  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.
    Children 6 to under 12 years of age1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.
    Children under 6 years of ageConsult a physician.
  • Other information

    Store at controlled room temperature 15º - 30ºC (59º-86ºF).

  • Inactive ingredients

    D&C Yellow # 10, FD&C Yellow # 6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Nivagen Pharmaceuticals, Inc
    Sacramento, CA 95827 USA
    Customer Service Number: 1-877-977-0687

  • PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

    NDC 75834-040-60

    NIVAGEN
    PHARMACEUTICALS

    Nivanex DMX™

    COUGH SUPPRESSANT • EXPECTORANT
    NASAL DECONGESTANT

    EACH TABLET CONTAINS:
    Dextromethorphan HBr
    15 mg
    Guaifenesin
    380 mg
    Phenylephrine HCl
    10 mg

    Tamper evident by foil seal under cap.
    Do not use if foil seal is broken or missing

    60 TABLETS

    PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    NIVANEX DMX 
    guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75834-040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN380 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code N040
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75834-040-6060 in 1 BOTTLE; Type 0: Not a Combination Product11/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/24/2014
    Labeler - Nivagen Pharmaceuticals, Inc. (052032418)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!