Label: DAYTIME NIGHTTIME SINUS RELIEF MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kit

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

Drug Label Information

Updated October 10, 2023

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

  • Active ingredients in Daytime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Active ingredients in Nighttime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCI 5 mg

  • Purpose for Daytime

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Purpose for Nighttime

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    DAYTIME

    • temporarily relieves
      • nasal congestion
      • headache
      • cough due to inhaled irritants
      • sinus congestion and pressure
      • minor aches and pains
      • 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

    NIGHTTIME

    • temporarily relieves
      • nasal congestion
      • cough due to inhaled irritants
      • headache
      • sinus congestion and pressure
      • minor aches and pains
      • runny nose and sneezing
    • promotes nasal and/or sinus drainage
  • Warnings

    DAYTIME and NIGHTTIME

    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day 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

    DAYTIME and NIGHTTIME

    • 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

    DAYTIME

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

    NIGHTTIME

    • liver disease
    • high blood pressure
    • diabetes
    • heart disease
    • thyroid disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem or chronic cough that lasts or 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

    DAYTIME

    taking the blood thinning drug warfarin

    NIGHTTIME

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product,

    DAYTIME

    do not use more than directed

    NIGHTTIME

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

    Stop use and ask a doctor if

    DAYTIME and NIGHTTIME

    • nervousness, dizziness, or sleeplessness
    • 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 coukld be signs of a serious condition.

    If pregnant or breast-feeding,

    DAYTIME and NIGHTTIME

    ask a health professional before use.

    Keep out of reach of children.

    DAYTIME and NIGHTTIME

    Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

    DAYTIME

    • do not take more than directed (see Overdose warning)
    • do not take more than 12 softgels (Daytime and NightTime) 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
    • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

    NIGHTTIME

    • do not take more than directed (see Overdose warning)
    • do not take more than 12 softgels (Daytime and Nighttime) 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
    • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing 
  • Other information

    DAYTIME and NIGHTTIME

    • swallow whole; do not crush, chew, or dissolve
    • store between 15-30ºC (59-86F)
    • avoid excessive heat
  • Inactive ingredients

    DAYTIME

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

    NIGHTTIME

    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitan*, sorbitol, titanium dioxide

  • Questions or comments?

    DAYTIME and NIGHTTIME

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    DAYTIME

    Sinus Relief

    Acetaminophen / Pain Reliever

    Dextromethorphan HBr / Cough Suppressant

    Guaifenesin / Expectorant

    Phenylephrine HCI / Nasal Decongestant

    MAXIMUM STRENGTH

    ALCOHOL FREE

    • Relieves sinus pressure, headache & congestion
    • Controls cough
    • thins & loosens mucus
    • For ages 12 years & over

    SOFTGELS*

    NIGHTTIME

    Sinus Relief

    Acetaminophen / Pain Reliever

    Dextromethorphan HBr/ Cough Suppressant

    Doxylamine Succinate / Antihistamine

    Phenylephrine HCI / Nasal Decongestant

    MAXIMUM STRENGTH

    ALCOHOL FREE

    • Relieves nasal congestion, sinus pressure & pain, runny nose & sneezing
    • Controls cough
    • For ages 12 years & over

    SOFTGELS*

    (*LIQUID-FILLED CAPSULES)

    Compare to Maximum Strength Mucinex® Sinus-Max® Day & Mucinex® Sinus-Max® Night active ingredients≠≠

    ≠≠This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com

  • Product Label

    Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCI 5 mg Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Doxylamine Succinate 6.25 mg, Phenylephrine HCI 5 mg

    WALGREENS Daytime Nighttime Sinus Relief

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME SINUS RELIEF  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0723
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0723-241 in 1 CARTON; Type 0: Not a Combination Product05/31/201602/28/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 18 BLISTER PACK
    Part 216 BLISTER PACK 16 
    Part 1 of 2
    NIGHTTIME SINUS RELIEF  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci capsule
    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 (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code 116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/31/201602/28/2025
    Part 2 of 2
    DAYTIME SINUS RELIEF 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci capsule
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code 341
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/31/201602/28/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/31/201602/28/2025
    Labeler - Walgreens (008965063)