Available Formats

• SPL UNCLASSIFIED SECTION

  Drug Facts

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• 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

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• Uses

  temporarily relieves nasal and sinus symptoms:

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

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• 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.

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• 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

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• Other information

  • store at room temperature

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• 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.

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• 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"

  

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• 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)

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