Label: SINUS RELIEF DAYTIME NIGHTTIME- acetaminophen, doxylamine succinate, phenylephrine hcl kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 20, 2013

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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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