Label: MAXIMUM STRENGTH MUCUS RELIEF COLD,FLU AND SORE THROAT- acetaminophen, dextromethorphan hydrobromide, guaifenesin ,phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)Purposes

    Acetaminophen 650 mg

    Pain reliever/fever reducer

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Guaifenesin 400 mg

    Expectorant

    Phenylephrine HCl 10 mg

    Nasal decongestant

  • Uses

    temporarily relieves these common cold and flu symptoms:
    nasal congestion
    sinus congestion and pressure
    cough due to minor throat and bronchial irritation
    minor aches and pains
    sore throat
    headache
    temporarily reduces fever
    temporarily promotes nasal and/or sinus drainage
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if you take:

    more than 6 doses in 24 hours, which is the maximum daily amount
    with other drugs containing acetaminophen
    3 or more alcoholic drinks daily while using this product

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    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

    liver disease
    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)

    Ask a doctor or pharmacist before use if

    you are taking the blood thinning drug warfarin

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    nervousness, dizziness, or sleeplessness occur
    pain, nasal congestion, or cough gets worse, or lasts more than 7 days
    fever gets worse, or lasts more than 3 days
    redness or swelling is present
    new symptoms occur
    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.

  • Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you don’t notice any signs or symptoms.

  • Directions

    do not take more than directed (see Overdose Warning))
    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 between 15-30°C (59-86°F)
    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?

    1-888-287-1915

  • Principal Display Panel

    equate™

    NDC 49035-771-09

    Compare to Mucinex® Fast-Max® Maximum Strength Cold, Flu & Sore Throat Active Ingredients*

    Maximum Strength‡

    Mucus Relief

    Cold, Flu & Sore Throat

    Acetaminophen - Pain Reliever/Fever Reducer
    Dextromethorphan HBr - Cough Suppressant
    Guaifenesin - Expectorant
    Phenylephrine HCl - Nasal Decongestant

    Relieves headache & fever
    Helps control cough
    Relieves nasal & chest congestion
    Thins & loosens mucus

    For Ages 12+

    9FL OZ (266mL)

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

    ‡Maximum Strength per 4 hour dose.

    Satisfaction guaranteed-Or we’ll replace it or give you your money back For questions or comments please call 1-888-287-1915

    Distributed by: Wal-Mart Stores, Inc.,

    Bentonville, AR 72716

    *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast-Max® Maximum Strength Cold, Flu & Sore Throat.

     

    equate Maximum Strength Mucus Relief Cold,Flu& Sore Throat
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MUCUS RELIEF COLD,FLU AND SORE THROAT 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin ,phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-771
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 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
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-771-09266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/06/2017
    Labeler - Wal-Mart Stores,Inc., (051957769)