Label: DAY AND NIGHT SINUS- acetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit

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

Drug Label Information

Updated November 4, 2024

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  • Active ingredients (in each caplet) (daytime)

    Acetaminophen 325 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever
    Expectorant
    Nasal decongestant

  • Active ingredients (in each caplet) (nighttime)

    Acetaminophen 325 mg
    Diphenhydramine HCl 12.5 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever
    Antihistamine/cough suppressant
    Nasal decongestant

  • Uses

    • temporarily relieves these common cold symptoms:
      • 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.
    • with any other product containing diphenhydramine, even one used on skin (nighttime only)

    Ask a doctor before use if you have

    • heart disease
    • diabetes
    • liver disease
    • thyroid disease
    • high blood pressure
    • 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)
    • avoid alcoholic beverages (nighttime only)
    • use caution when driving a motor vehicle or operating machinery (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
    • 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.

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

    Do not take DAYTIME and NIGHTTIME products at the same time.

  • Directions

    • do not take 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

    • each caplet contains: sodium 3 mg (daytime only)
    • 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?

    1-888-287-1915

  • Principal Display Panel

    equate™

    NDC 49035-356-09

    Maximum Strength
    Day & Night Sinus

    Day

    Acetaminophen - Pain Reliever,
    Guaifenesin - Expectorant,
    Phenylephrine HCl / Nasal Decongestant

    • Relieves sinus pressure,
    headache & congestion
    • Thins & loosens mucus

    Actual Size

    10
    DAYTIME
    CAPLETS

    Night

    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
    NIGHTTIME
    CAPLETS

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

    Do not take Daytime and Nighttime
    products at the same time.

    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716

    50844    REV0824B61569409

    Equate 44-615694-09

    Equate 44-615694-09

  • INGREDIENTS AND APPEARANCE
    DAY AND NIGHT SINUS 
    acetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-356
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-356-091 in 1 CARTON; Type 0: Not a Combination Product10/23/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 10 
    Part 21 BLISTER PACK 10 
    Part 1 of 2
    DAY SINUS 
    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, UNSPECIFIED (UNII: 2S7830E561)  
    FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)  
    FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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 DrugM01210/23/2020
    Part 2 of 2
    NIGHT SINUS 
    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, UNSPECIFIED (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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 DrugM01210/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/23/2020
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(49035-356)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(49035-356) , pack(49035-356)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(49035-356)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(49035-356)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(49035-356)
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