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N - TIME SINUS (SPIRIT PHARMACEUTICALS,LLC)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 5000 CAPSULE, LIQUID FILLED in 1 DRUM (68210-1480-5) Label Information
CAPSULE, LIQUID FILLED 6000 CAPSULE, LIQUID FILLED in 1 DRUM (68210-1480-6) Label Information

Complete N - TIME SINUS Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients for NyQuil Sinus (in each LiquiCap) Purpose
    Acetaminophen 325 mg Pain reliever
    Doxylamine succinate 6.25 mg Antihistamine
    Phenylephrine HCl 5 mg Nasal decongestant

  • Uses

    temporarily relieves nasal and sinus symptoms:

    • sinus pain
    • headache
    • nasal and sinus congestion
    • runny nose and sneezing (NyQuil Sinus only)

  • Warnings

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

    • more than 6 doses in 24 hours
    • 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). Ask a doctor or pharmacist before using with other drugs if you are not sure
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkison'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
    • trouble urinating due to enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using these products

    • do not use more than directed

    In addition, when using NyQuil Sinus:

    • 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, and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

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

    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 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 as well as for children even if you do not notice any signs or symptoms.


  • Directions

    • take only as recommended - see Overdose warning
    • do not exceed 6 doses per 24 hours

    NyQuil Sinus OR DayQuil Sinus

    adults and children
    12 years and over
    2 LiquiCaps with
    water every 4 hours
    children 2 to under 12 years ask a doctor
    children under 2 years do not use
    • when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

  • Other information

    • store at room temperature

  • Inactive ingredients

    NyQuil Sinus FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.

    DayQuil Sinus FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.


  • PRINCIPAL DISPLAY PANEL - 6000 Softgel Label

    N-Time Sinus Soft Gelatin Capsules

    Each Softgel Contains:
    Acetaminophen USP 325mg
    Doxylamine Succinate USP 6.25mg
    Phenylephrine HCL USP 5mg

    LOT NO : NDC NO : 68210-1480-6
    MFG DATE : QUANTITY : 6000 Softgels
    EXP DATE : GROSS WT. :

    WARNING:
    KEEP OUT OF REACH OF CHILDREN

    STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
    CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.

    MANUFACTURED BY:
    Marksans Pharma Ltd
    VERNA, GOA-403722,
    INDIA.
    CODE : GO/DRUGS/515

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS, PA 19030
    PH.# 215 943 4000
    FAX.# 215 943 4039

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    Principal Display Panel - 6000 Softgel Label

  • INGREDIENTS AND APPEARANCE
    N - TIME SINUS 
    acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1480
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    PHENYLEPHRINE Hydrochloride (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE Hydrochloride 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code 130
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-1480-5 5000 in 1 DRUM
    2 NDC:68210-1480-6 6000 in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 03/01/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)