SINUS RELIEF DAYTIME NIGHTTIME (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WALGREEN CO.]

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  • SINUS RELIEF DAYTIME NIGHTTIME (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WALGREEN CO.]

SINUS RELIEF DAYTIME NIGHTTIME (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WALGREEN CO.]
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NDC 0363-0555-22
Set ID 3bc85233-9365-40bb-b2bd-07b696853131
Category HUMAN OTC DRUG LABEL
Packager WALGREEN CO.
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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  • Active ingredients (in each liquid cap)

    Acetaminophen 325 mg
    Phenyelphrine HCl 5 mg

  • Purpose

    Pain reliever
    Nasal decongestnat 

  • Uses

    • temporarily relieves nasal and sinus symptoms:
      • sinus pain
      • headache
      • nasal and sinus congestion
  • Warnings

    Liver warning: This product contains acetaminophen.  Severe liver damage may occur if you take:

    • more than 12 liquid caps in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminohen
    • 3 or more alcoholic drinks every ay while using this product

    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
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland 

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    When using this product

    • do not exceed recommended dosage

    Stop use and ask a doctor if

    • redness or swellling is present
    • nervousness, dizziness, or sleeplessness occur
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur

    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: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center right away.  Quickmedical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as recommended (see overdose warning)
    • adults and children 12 years and over
      • 2 liquid caps with water every 4 hours
      • do not take more than 12 liquid caps in 24 hours
    • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
    • for better identification, keep liquid caps in carton until used
  • Inactive ingredients

    edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

  • Active ingredient (in each liquid cap)

    Acetaminophen 325 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever
    Antihistamine
    Nasal decongestant 

  • Uses

    • temporarily relieves nasal and sinus symptoms:
      • headache
      • sinus pain
      • nasal and sinus congestion
      • runny nose and sneezing
  • Warnings

    Liver warning: This product contains acetaminophen.  Severe liver damage may occur if you take:

    • more than 12 liquid caps in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminohen
    • 3 or more alcoholic drinks every ay while using this product

    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

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • glaucoma
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    •  do not exceed recommended dosage
    • excitability may occur, expecially 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

    • redness or swellling is present
    • nervousness, dizziness, or sleeplessness occur
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur

    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: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center right away.  Quickmedical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as recommended (see overdose warning)
    • adults and children 12 years and over
      • 2 liquid caps with water every 4 hours
      • do not take more than 12 liquid caps in 24 hours
    • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage 
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
    • for better identification, keep liquid caps in carton until used
  • Inactive ingredients

    edible white ink, FD&C blue #1, gelatin, glyercin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    COMBO PACK

    Well at
    Walgreens
    WALGREENS PHARMACIST RECOMMENDEDǂ

    NDC 0363-0555-22

    NON-DROWSY • DAYTIME
    Sinus Relief
    Acetaminophen     /
    Sinus Headache & Pain
    Phenylephrine HCl /
    Sinus Pressure
    & Congestion

    32 LIQUID CAPS

    NGHTTIME
    Sinus Relief
    Acetaminophen     /
    Sinus Headache & Pain
    Doxylamine Succinate /
    Runny Nose
    Phenylephrine HCl /
    Sinus Pressure & Congestion

    16 LIQUID CAPS

    Compare to Vicks® DayQuil® & NyQuil® Sinex® Sinus Relief LiquiCaps® active ingredientsǂǂ

    48 TOTAL LIQUID CAPS

    ǂWalgreens Pharmacist Survey Study, November 2010
    ǂǂThis product is not manufactured  or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength Tablets.

    50844    REV1012.553/554A22

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

    Walgreens 44-553/554

    Walgreens 44-553/554

  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF DAYTIME NIGHTTIME 
    acetaminophen, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0555
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0555-221 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BLISTER PACK 32   in 4 
    Part 22 BLISTER PACK 16   in 2 
    Part 1 of 2
    NON DROWSY DAYTIME SINUS RELIEF 
    acetaminophen, phenylephrine hcl capsule
    Product Information
    Item Code (Source)NDC:0363-0000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize17mm
    FlavorMINTImprint Code 48A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/15/2005
    Part 2 of 2
    NIGHTTIME SINUS RELIEF 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
    Product Information
    Item Code (Source)NDC:0363-0009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 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
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize17mm
    FlavorMINTImprint Code 47A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/21/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/21/2005
    Labeler - WALGREEN CO. (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accucaps Industries, Ltd.248441727MANUFACTURE(0363-0555, 0363-0000, 0363-0009)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(0363-0555, 0363-0000, 0363-0009)
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