N - TIME SINUS- acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled

N - TIME SINUS by

Drug Labeling and Warnings

N - TIME SINUS by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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"

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)