Label: SINUS PE CONGESTION DAYTIME NIGHTTIME- diphenhydramine hcl, phenylephrine hcl kit

  • NDC Code(s): 79481-4534-1, 79481-7453-2, 79481-7485-3
  • Packager: Meijer Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 5, 2023

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  • Active ingredient (in each tablet) (Sinus Day)

    Phenylephrine HCl 10 mg

  • Purpose

    Nasal decongestant

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

    Diphenhydramine HCl 25 mg
    Phenylephrine HCl 10 mg

  • Purpose

    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • nasal congestion
      • sneezing (Nighttime only)
      • runny nose (Nighttime only)
      • itchy, watery eyes (Nighttime only)
      • itching of the nose or throat (Nighttime only)
    • temporarily relieves these symptoms due to the common cold:
      • nasal congestion
      • sneezing (Nighttime only)
      • runny nose (Nighttime only)
    • temporarily relieves sinus congestion and pressure
  • Warnings

    Do not use

    • 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
    • thyroid disease
    • high blood pressure
    • difficulty in urination due to enlargement of the prostate gland
    • 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 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

    • symptoms do not improve within 7 days or occur with fever
    • nervousness, dizziness, or sleeplessness occur

    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.

    Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

  • Directions

    • adults and children 12 years and over
      • take 1 tablet every 4 hours
      • do not take more than 6 tablets in 24 hours
    • children under 12 years: do not use
  • Other information

    • each tablet contains: calcium 25 mg (Nighttime 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)

    croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

  • Inactive ingredients (Nighttime only)

    croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    meijer®

    COMBO PACK
    20 TABLETS TOTAL

    NDC 79481-4534-1

    COMPARE TO
    DAYTIME SUDAFED PE®
    SINUS CONGESTION ACTIVE INGREDIENT*
    COMPARE TO
    NIGHTTIME SUDAFED PE®
    SINUS CONGESTION
    ACTIVE INGREDIENTS*

    NON-DROWSY

    Daytime
    Sinus PE Congestion

    PHENYLEPHRINE HCI 10 mg
    NASAL DECONGESTANT

    Pseudoephedrine Free

    Relieves
    Nasal Congestion

    12
    Tablets
    actual size

    Nighttime
    Sinus PE Congestion 

    DIPHENHYDRAMINE HCl 25 mg
    PHENY    LEPHRINE HCl 10 mg
    Antihistamine
    Nasal Decongestant

    Pseudoephedrine Free

    Relieves
    Nasal Congestion,
    Runny Nose

    8
    Tablets
    actual size

    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 Kenvue Inc., owner
    of the registered trademark Sudafed
    PE® Sinus Congestion Daytime
    and Nighttime.

    50844 ORG082045348509

    DIST. BY MEIJER
    DISTRUBUTION, INC.
    GRAND RAPIDS, MI 49544
    www.meijer.com

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

    meijer 44-453485

    meijer 44-453485

     

  • INGREDIENTS AND APPEARANCE
    SINUS PE CONGESTION  DAYTIME NIGHTTIME
    diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-4534
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-4534-11 in 1 CARTON; Type 0: Not a Combination Product07/05/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK 8 
    Part 1 of 2
    SINUS PE CONGESTION  DAYTIME
    phenylephrine hcl tablet, film coated
    Product Information
    Item Code (Source)NDC:79481-7453
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;453
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-7453-212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/05/2023
    Part 2 of 2
    SINUS PE CONGESTION  NIGHTTIME
    diphenhydramine hcl, phenylephrine hcl tablet, film coated
    Product Information
    Item Code (Source)NDC:79481-7485
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;485
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-7485-38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/05/2023
    Labeler - Meijer Distribution, Inc. (006959555)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(79481-4534) , pack(79481-4534)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(79481-4534)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(79481-4534)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(79481-4534)
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