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

  • NDC Code(s): 63868-464-48
  • Packager: Chain Drug Marketing Association Inc.
  • 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 December 30, 2019

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  • Active ingredients for Nighttime Sinus (in each softgel)

    Acetaminophen 325 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

  • Active ingredients for Daytime Sinus (in each softgel)

    Acetaminophen 325 mg
    Phenylephrine hydrochloride 5 mg

  • Purposes

    Nighttime Sinus Relief

    Pain reliever/Fever reducer

    Antihistamine

    Nasal decongestant

  • Purposes

    Daytime Sinus Relief

    Pain reliever/Fever reducer

    Nasal decongestant

  • Uses

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

    Liver warning

    These products contain acetaminophen. Severe liver damage may occur if you take

    • more than 10 softgels in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day 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. 
    • to make a child sleep (Nighttime only)    

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    • do not use more than directed, in addition when using Nighttime Sinus and Congestion:
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives & tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • pain or nasal congestion gets worse or last more than 7 days            
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present 
    • new symptoms occur
    • you get nervous, dizzy or sleepless  

    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. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed
    • do not exceed 4 doses per 24 hours

    Age

    Daytime Sinus

    Nighttime Sinus

    adults and children 12 years and over

    2 softgels with water every 4 hours

    2 softgels with water every 4 hours

    children 4 to under 12 years

    ask a doctor

    ask a doctor

    children under 4 years

    do not use

    do not use

  • Other information

    • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • Inactive ingredients

    Nighttime Sinus: FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

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

  • Questions or comments?

    Call 248-449-9300

  • Principal Display Panel

    CDMA Daytime Sinus Relief and Nighttime Sinus Relief 48 SOFTGELS

    NDC 63868-464-48

    Compare to the active ingredients in Vicks® QlearQuilTM Daytime Sinus & Congestion and Nighttime Sinus & Congestion*

    Carton Label 1

    Carton Label 2

  • INGREDIENTS AND APPEARANCE
    DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF 
    acetaminophen, doxylamine succinate, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-464
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-464-481 in 1 CARTON; Type 0: Not a Combination Product04/12/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BLISTER PACK 32 
    Part 22 BLISTER PACK 16 
    Part 1 of 2
    DAYTIME SINUS RELIEF 
    acetaminophen, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    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
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colororange (clear) Scoreno score
    Shapecapsule (oblong) Size20mm
    FlavorImprint Code PC12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 CARTON
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/12/2017
    Part 2 of 2
    NIGHTTIME SINUS RELIEF 
    acetaminophen, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorblue (clear) Scoreno score
    Shapecapsule (oblong) Size20mm
    FlavorImprint Code PC13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 CARTON
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/12/2017
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(63868-464) , analysis(63868-464)
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