SINUS RELIEF DAYTIME, NIGHTTIME, MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]

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  • SINUS RELIEF DAYTIME, NIGHTTIME, MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]

SINUS RELIEF DAYTIME, NIGHTTIME, MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]
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NDC 69842-882-09
Set ID f6b3ca40-7638-477f-b800-4c28c40ff0a8
Category HUMAN OTC DRUG LABEL
Packager CVS PHARMACY
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each caplet)(Sinus Day)

    Acetaminophen 325 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever
    Expectorant
    Nasal decongestant

  • Active ingredients (in each caplet)(Sinus Night)

    Acetaminophen 325 mg
    Diphenhydramine HCl 12.5 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever
    Antihistamine/cough suppressant
    Nasal decongestant

  • Uses

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

    Liver warning: This product contains 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

    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • with any other product containing diphenhydramine, even one used on skin (Nighttime only)

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • liver disease
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
    • glaucoma (Nighttime only)

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Nighttime only)

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children (Nighttime only)
    • marked drowsiness may occur (Nighttime only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
    • be careful when driving a motor vehicle or operating machinery (Nighttime only)
    • avoid alcoholic beverages (Nighttime 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
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • 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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

  • Directions

    • do not use more than directed
    • do not take more than 12 caplets in any 24-hour period
    • adults and children 12 years and over: take 2 caplets every 4 hours
    • children under 12 years: do not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients (Daytime only)

    corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Inactive ingredients (Nighttime only)

    corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

     ♥︎CVS Health™

    Compare to the active ingredients in Maximum
    Strength Mucinex® SINUS-MAX® Day & Night*

     Sinus Pain

     

    Daytime
    MAXIMUM STRENGTH
    Sinus Relief

    ACETAMINOPHEN - Pain reliever
    GUAIFENESIN - Expectorant
    PHENYLEPHRINE HCl - Nasal decongestant

    Relieves:
    Sinus pressure &
    Congestion, Headache
    Thins & loosens mucus

    Actual Size

    10 CAPLETS  For Ages 12 +

    NDC 69842-882-09    
     

    Nighttime
    MAXIMUM STRENGTH
    Sinus Relief

    ACETAMINOPHEN - Pain reliever
    DIPHENHYDRAMINE HCl - Antihistamine/
    Cough suppressant
    PHENYLEPHRINE HCl - Nasal decongestant

    Relieves:
    Nasal congestion, Sinus
    pressure & Pain, Runny nose,
    Sneezing & Cough

    Actual Size

    10 CAPLETS   For Ages 12 +

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

    *This product is not manufactured or distributed by
    Reckitt Benckiser LLC, owner of the registered trademark
    Maximum Strength Mucinex® SINUS-MAX® Day & Night.
    50844                  ORG051761569409

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2017 CVS/pharmacy CVS.com®
    1-800-SHOP CVS

    V-19849

    ✓CVS® Quality
    Money Back Guarantee

    CVS 44-615694

    CVS 44-615694

  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF  DAYTIME, NIGHTTIME, MAXIMUM STRENGTH
    acetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-882
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-882-091 in 1 CARTON; Type 0: Not a Combination Product07/01/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 10 
    Part 21 BLISTER PACK 10 
    Part 1 of 2
    SINUS RELIEF  DAYTIME, MAXIMUM STRENGTH
    acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;615
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/2013
    Part 2 of 2
    SINUS RELIEF  NIGHTTIME, MAXIMUM STRENGTH
    acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;694
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2017
    Labeler - CVS PHARMACY (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(69842-882)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(69842-882)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(69842-882)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(69842-882)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(69842-882)
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