Label: MUCINEX RAPID CLEAR PAIN, HEADACHE, AND MUCUS CONGESTION AND SINUS MAX CLEAR AND COOL- oxymetazoline hydrochloride, acetaminophen and guaifenesin kit

  • NDC Code(s): 63824-129-17, 72854-211-08, 72854-216-02
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2025

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose
    Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant

    Active ingredients (in each capsule) Purposes
    Acetaminophen 325 mg.........................................Pain reliever/fever reducer
    Guaifenesin 200 mg...................................................................Expectorant

  • INDICATIONS & USAGE

    Uses
    ■ temporarily relieves nasal congestion due to:
    ■ a cold ■ hay fever or other upper respiratory allergies
    ■ promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure
    ■ helps clear nasal passages; shrinks swollen membranes

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

  • WARNINGS

    Warnings
    Ask a doctor before use if you have
    ■ heart disease ■ high blood pressure
    ■ thyroid disease ■ diabetes
    ■ difficulty in urination due to enlargement of the prostate gland
    When using this product
    ■ do not exceed recommended dosage
    ■ do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use
    may cause nasal congestion to recur or worsen.
    ■ this product may cause temporary discomfort such as burning, stinging, sneezing, or an
    increase in nasal discharge
    ■ the use of this container by more than one person may spread infection

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
    ■ more than 12 capsules in 24 hours, which is the maximum daily amount for this product
    ■ with other drugs containing acetaminophen
    ■ 3 or more alcoholic drinks daily while using this product
    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.
    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.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each
    nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    ■ children under 6 years of age: consult a doctor.
    Shake well before use.
    To open, hold by the white grips then squeeze, push down firmly and turn cap counterclockwise.
    Before using for the first time, remove the protective cap from the tip and prime metered pump
    by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle
    between first and second fingers.Without tilting head, insert nozzle into nostril. Fully depress
    pump all the way down with a firm even stroke and sniff deeply.Wipe nozzle clean after use.
    To close, turn cap clockwise.
    DO NOT DISCARD CAP.

    Directions
    ■ do not take more than directed (see Overdose warning)
    ■ do not take more than 12 capsules in any 24-hour period
    ■ adults and children 12 years of age and over: take 2 capsules every 4 hours
    ■ children under 12 years of age: do not use

  • OTHER SAFETY INFORMATION

    Other information
    ■ store at 20-25°C (68-77°F)

    ■ avoid excessive heat

  • INACTIVE INGREDIENT

    Inactive ingredients
    benzalkonium chloride, benzododecinium chloride, camphor, cetalkonium chloride, colloidal
    silicon dioxide, edetate disodium, eucalyptol, glycine, linoleic acid, linolenic acid, menthol,
    myristalkonium chloride, myristic acid, oleic acid, palmitic acid, palmitoleic acid, polyethylene
    glycol, polysorbate 80, propylene glycol, purified water, sodium carbonate, sodium chloride,
    sodium hydroxide, stearic acid

    Inactive ingredients
    FD&C blue no.1, gelatin, glycerin, hypromellose, lecithin, light mineral oil, polyethylene glycol,
    povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children

  • PURPOSE

    Purpose


    Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant

    Acetaminophen 325 mg.........................................Pain reliever/fever reducer
    Guaifenesin 200 mg...................................................................Expectorant

  • PRINCIPAL DISPLAY PANEL

    full carton label

    back label

  • INGREDIENTS AND APPEARANCE
    MUCINEX RAPID CLEAR PAIN, HEADACHE, AND MUCUS CONGESTION AND SINUS MAX CLEAR AND COOL 
    oxymetazoline hydrochloride, acetaminophen and guaifenesin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-216
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-216-021 in 1 CARTON05/01/2025
    11 in 1 CARTON; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE, PUMP 1 mL
    Part 20 BLISTER PACK
    Part 1 of 2
    MUCINEX SINUS-MAX  SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL NASAL
    oxymetazoline hydrochloride solution
    Product Information
    Item Code (Source)NDC:63824-129
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    BENZODODECINIUM CHLORIDE (UNII: Y5A751G47H)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-129-171 in 1 CARTON
    122 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2025
    Part 2 of 2
    MUCINEX SINUS MAX CLEAR AND COOL 
    acetaminophen and guaifenesin capsule, liquid filled
    Product Information
    Item Code (Source)NDC:72854-211
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize23mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-211-081 in 1 CARTON
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2025
    Labeler - RB Health (US) LLC (081049410)