DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [CHAIN DRUG MARKETING ASSOCIATION INC.]

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  • DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [CHAIN DRUG MARKETING ASSOCIATION INC.]

DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [CHAIN DRUG MARKETING ASSOCIATION INC.]
PDF | XML
NDC 63868-464-48
Set ID d538445e-a47d-4983-844f-38aa303d11fd
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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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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