Label: MAXIMUM STRENGTH MUCUS RELIEF SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

  • 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 1, 2017

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 20 mL)    		Purposes

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Guaifenesin 400 mg

    Expectorant

    Phenylephrine HCl 10 mg

    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
    •
    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

    •
    do not take more than 6 doses in any 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
    •
    store at room temperature
    •
    do not refrigerate
    •
    dosing cup provided
  • Inactive ingredients

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

  • Questions or comments?

    1-866-932-7948

  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    EQUALINE®

    NDC 41163-738-06

    Compare toMucinex® Fast- Max™ Maximum strength Severe Congestion & Cough active ingredients*

    maximum strength‡

    severe congestion and cough


    dextromethorphan HBr (cough suppressant)
    guaifenesin (expectorant)
    phenylephrine HCl (nasal decongestant)

    •
    controls cough
    •
    relieves nasal and chest congestion
    •
    thins and loosens mucus

    6 FL OZ (180 mL)


    for ages 12+

    Tamper evident: do not use if printed seal under cap is broken or missing.

    ‡Maximum Strength per 4 hour dose.

    DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA

    877-932-7948, supervaluprivatebrands.com

    ‡Maximum Strength per 4 hour dose.

    *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ®

    Fast -Max® Maximum Strength Severe Congestion & Cough.

    Equaline maximum strength mucus relief severe congestion and cough 6 FL OZ (180 mL)
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MUCUS RELIEF SEVERE CONGESTION AND COUGH 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-738
    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)  
    Product Characteristics
    ColorBLUE (viscous liquid) Score    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-738-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/07/2017
    Labeler - SuperValu Inc., (006961411)
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!