Medication Guide App

N - TIME SINUS

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE Hydrochloride 5mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-1480

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.

N-Time Sinus Soft Gelatin Capsules

Drug Facts

Active ingredients for NyQuil Sinus (in each LiquiCap)Purpose
Acetaminophen 325 mgPain reliever
Doxylamine succinate 6.25 mgAntihistamine
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 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 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 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"

N - TIME SINUS 
acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1480
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE Hydrochloride (PHENYLEPHRINE) PHENYLEPHRINE Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
GELATIN 
POVIDONE 
SORBITOL 
WATER 
GLYCERIN 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize18mm
FlavorImprint Code130
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-1480-55000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 DRUM
2NDC:68210-1480-66000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2010
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Revised: 07/2010
 
SPIRIT PHARMACEUTICALS,LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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