Label: MAXIMUM STRENGTH SINUS RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 29, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • MAXIMUM STRENGTH** Sinus Relief Day

    Drug Facts

  • Active ingredients (in each softgel) DAY

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves:
    • nasal congestion • headache • cough  • minor aches & pains • sinus congestion & pressure
    • 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 12 softgels in 24 hours, which is the maximum daily amount 
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using these 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 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 these products  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 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: In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

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

  • Other information

    • store at 20-25°C (68-77°F)
    • protect from light, heat and moisture

  • Inactive ingredients

    edible printing ink, FD&C Blue no. 1, FD&C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments?

    Call: 1-888-423-0139

  • MAXIMUM STRENGTH** Sinus Relief Night

    Drug Facts

  • Active ingredients (in each softgel) NIGHT

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever
    Cough suppressant
    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves:
    • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • runny nose and sneezing
    • temporarily promotes nasal and/or sinus drainage

  • Warnings

    Liver warning: This product contains acetaminophen.
    Severe liver damage may occur if you take:
    • more than 12 softgels in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using these products

    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 enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • 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

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

    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 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: In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

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

  • Other information

    • store at 20-25°C (68-77°F)
    • protect from light, heat and moisture

  • Inactive ingredients

    edible printing ink, FD&C Blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments?

    Call: 1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    COMPARE TO MUCINEX® SINUS-MAX® DAY ACTIVE INGREDIENTS*

    COMPARE TO MUCINEX® SINUS-MAX® NIGHT ACTIVE INGREDIENTS*

    DAY TIME FOR AGES 12+
    NIGHT TIME FOR AGES 12+

    *These products are not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Sinus-Max® Day & Night Softgel 

    **Per 4-hour dose.

    Do not take DAY & NIGHT softgels at the same time. Do not take more than a total of 12 softgels in a 24-hour period. Do not take the first dose of the NIGHT softgels sooner than 4 hours after the last dose of the DAY softgels unless directed by a doctor.

    Take only as directed.

    READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

    DISTRIBUTED BY
    TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

    Product of United Arab Emirates

    REV.01-042023  CT7616282412

  • Packaging

    Topco-824

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH SINUS RELIEF 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-824
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-824-121 in 1 CARTON; Type 0: Not a Combination Product12/25/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 16 
    Part 22 BLISTER PACK
    Part 1 of 2
    MAXIMUM STRENGTH SINUS RELIEF DAY 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:76162-825
    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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 811
    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 DrugM01212/25/2023
    Part 2 of 2
    MAXIMUM STRENGTH SINUS RELIEF NIGHT 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:76162-826
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 812
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/25/2023
    Labeler - Topco Associates LLC (006935977)