Label: MUCINEX SINUS-MAX DAY AND NIGHT MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, and phenylephrine hydrochloride kit

  • 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 December 16, 2021

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each liquid gel)
    Mucinex SINUS-MAX DAY    		Purposes
    Acetaminophen 325 mgPain reliever
    Dextromethorphan HBr 10 mgCough suppressant
    Guaifenesin 200 mgExpectorant
    Phenylephrine HCl 5 mgNasal decongestant
    Active ingredients (in each liquid gel)
    Mucinex SINUS-MAX NIGHT    		Purposes
    Acetaminophen 325 mgPain reliever
    Dextromethorphan HBr 10 mgCough suppressant
    Doxylamine succinate 6.25 mgAntihistamine
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves:
      • nasal congestion
      • headache
      • cough
      • minor aches and pains
      • sinus congestion and pressure
      • runny nose and sneezing (NIGHT only)
    • 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 (DAY only)
  • Warnings

    Liver warning

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

    • more than 12 liquid gels in 24 hours, which is the maximum daily amount
    • 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.

    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.
    • 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
    • diabetes
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • glaucoma (NIGHT only)
    • a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
    • 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
    • taking sedatives or tranquilizers (NIGHT only)

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children (NIGHT only)
    • marked drowsiness may occur (NIGHT only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
    • avoid alcoholic drinks (NIGHT only)
    • be careful when driving a motor vehicle or operating machinery (NIGHT only)

    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 fever, rash, or headache that lasts. 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 take more than directed (see Overdose warning)
    • do not take more than 12 liquid gels in any 24-hour period
    • adults and children 12 years of age and over: take 2 liquid gels every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • store at 20-25°C (68-77°F)
    • avoid excessive heat
  • Inactive ingredients (DAY only)

    FD&C yellow no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

  • Inactive ingredients (NIGHT only)

    D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

  • Questions?

    1-866-MUCINEX (1-866-682-4639)

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Fast Dissolving Liquid Gels!

    NDC 72854-204-24

    MAXIMUM STRENGTH

    Mucinex®
    SINUS-MAX®

    DAY

    Acetaminophen – Pain Reliever
    Dextromethorphan HBr - Cough Suppressant
    Guaifenesin – Expectorant
    Phenylephrine HCl – Nasal Decongestant

    ✓
    Relieves Sinus Pressure, Headache
    & Congestion
    ✓
    Controls Cough
    ✓
    Thins & Loosens Mucus

    Actual Size

    16
    LIQUID GELS
    (Liquid Filled
    Capsules)

    NIGHT

    Acetaminophen – Pain Reliever
    Dextromethorphan HBr - Cough Suppressant
    Doxylamine Succinate - Antihistamine
    Phenylephrine HCl - Nasal Decongestant

    ✓
    Relieves Nasal Congestion,
    Sinus Pressure & Pain
    ✓
    Controls Cough
    ✓
    Relieves Runny Nose & Sneezing

    Actual Size

    8
    LIQUID GELS
    (Liquid Filled
    Capsules)

    FOR AGES 12+

    TOTAL 24
    LIQUID GELS

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX SINUS-MAX DAY AND NIGHT   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, and phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-204
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-204-241 in 1 CARTON07/26/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 16 
    Part 21 BLISTER PACK 8 
    Part 1 of 2
    MUCINEX SINUS-MAX DAY   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize26mm
    FlavorImprint Code AR01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart34107/26/2021
    Part 2 of 2
    MUCINEX SINUS-MAX NIGHT   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code AR03
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart34107/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/26/2021
    Labeler - RB Health (US) LLC (081049410)
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