N - Time Sinus
FDA Label NDC 68210-1480

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals,llc for the product N - Time Sinus (NDC 68210-1480). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding uses, warnings, directions, other information, inactive ingredients, principal display panel - 6000 softgel label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

    • 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"

Principal Display Panel (6000 Softgel Label)

Principal Display Panel (6000 Softgel Label)

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