NIGHTTIME SINUS (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]

NIGHTTIME SINUS (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]
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NDC 53345-031-01
Set ID 0f3b1404-9252-470a-aa8c-b360c85731f3
Category HUMAN OTC DRUG LABEL
Packager Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • Active ingredients (in each softgel)

    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:

    • sinus pain 
    • headache  
    • 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 4 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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                                                                                                          

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    • do not use more than directed
    • 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

    • redness or swelling is present 
    • you get nervous, dizzy or sleepless              
    • fever gets worse or lasts more than 3 days
    • new symptoms occur       
    • symptoms do not get better within 7 days or are accompanied by a fever 

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed - see Overdose warning
    • do not exceed 4 doses per 24 hrs

    adults and children 12 years of age and over

     take 2 softgels with water every 4 hrs

    Children 4 to under 12 years of age

     ask a doctor

    children under 4 years of age

    do not use
    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
  • Other information

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

    FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, white edible ink

    Manufactured by:
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
    Wuhan, Hubei
    430206, China

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    NightTime Sinus Capsules

    Quantity : 4000 Capsules
    NDC. No : 53345-031-01

    IMPORTANT:

    Inspect immediate upon receipt.
    This is a bulk shipment, intended for further processing only.
    Protect from heat, humidity, and light. Do not refrigerate.

    CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING"

    Shipping Label

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SINUS 
    acetaminophen, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-031
    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
    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
    ColorblueScoreno score
    ShapeCAPSULE (oblong) Size21mm
    FlavorImprint Code 665
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-031-011 in 1 BOX02/26/2015
    14000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/26/2015
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287MANUFACTURE(53345-031) , ANALYSIS(53345-031)

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