Label: MUCUS RELIEF COLD AND SINUS MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl liquid

  • NDC Code(s): 55910-033-09
  • Packager: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
  • 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 October 24, 2022

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

  • Active ingredients (in each 20 mL)

    Acetaminophen 650 mg 

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer 

    Expectorant

    Nasal decongestant

  • Uses

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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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 everyday 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

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

    Ask a doctor before use if you have

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

    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

    • redness or swelling is present
    • nervousness, dizziness or sleeplessness occur
    • new symptoms occur
    • pain, nasal congestion or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not exceed recommended dose (see overdose warning)
    • do not take more than 6 doses in a 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 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 12 mg
    • store at room temperature. Do not refrigerate
  • Inactive ingredients

    anhydous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate, sorbitol, sucralose, xanthan gum

  • Principal Display Panel

    Ages 12 and over 

    Maximum Strength

    Fast-Acting

    Mucus Relief

    Cold & Sinus

    Multi-Symptom Relief

    Acetaminophen

    Guaifenesin

    Phenylephrine HCl

    Pain reliever/fever reducer

    Expectorant

    Nasal decongestant

    Compare to active ingredients in Mucinex® Fast-Max® Maximum Strength Cold & Sinus Liquid*

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

    888-309-9030

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

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

  • Package Label

    Acetaminophen 650 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg

    Dollar General Maximum Strength Mucus Relief Cold and Sinus Liquid

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF COLD AND SINUS  MAXIMUM STRENGTH
    acetaminophen, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-033-09266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201401/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/201401/31/2025
    Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)