FDA Label for N - Time Sinus
View Indications, Usage & Precautions
N - Time Sinus Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals,llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Directions
- take only as recommended - see Overdose warning
- do not exceed 6 doses per 24 hours
- when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing
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 |
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"
* Please review the disclaimer below.