Label: D TIME SINUS- acetaminophen and phenylephrine hydrochloride capsule, liquid filled

  • 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 July 26, 2010

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients for DayQuil Sinus (in each LiquiCap)Purpose
    Acetaminophen 325 mgPain reliever
    Phenylephrine HCl 5 mgNasal 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 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
    • 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 yearsdo 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 Softgels

    D-Time Sinus Soft Gelatin Capsules
    Each Softgel Contains:
    Acetaminophen USP 325mg
    Phenylephrine HCL USP 5mg

    LOT NO :NDC NO : 68210-1470-6
    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
  • INGREDIENTS AND APPEARANCE
    D TIME SINUS 
    acetaminophen and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1470
    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 GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 129
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1470-51 in 1 DRUM
    15000 in 1 BAG
    2NDC:68210-1470-61 in 1 DRUM
    26000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/01/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)