D TIME SINUS description, usages, side effects, indications, overdosage, supplying and lots more!

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D TIME SINUS

SPIRIT PHARMACEUTICALS,LLC

D-Time Sinus Soft Gelatin Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients for DayQuil Sinus (in each LiquiCap) Purpose
Acetaminophen 325 mg Pain reliever
Phenylephrine HCl 5 mg Nasal decongestant

D TIME SINUS 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 Parkinson'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

D TIME SINUS 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 Softgels

D-Time Sinus Soft Gelatin Capsules
Each Softgel Contains:
Acetaminophen USP 325mg
Phenylephrine HCL USP 5mg

LOT NO : NDC NO : 68210-1470-6
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"

D TIME SINUS

D TIME SINUS

ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68210-1470
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
propylene glycol
GELATIN
povidone
sorbitol
water
GLYCERIN
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
ORANGE 18 mm 129 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5000 in 1 BAG
2 6000 in 1 BAG
3 NDC:68210-1470-6 1 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-03-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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