NON-DROWSY DAYTIME SINUS RELIEF

PuraVation Pharmaceuticals Inc

NON-DROWSY DAYTIME SINUS RELIEF capsule, liquid filled

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each softgel)
• Purpose
• NON-DROWSY DAYTIME SINUS RELIEF Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• NON-DROWSY DAYTIME SINUS RELIEF Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - 20 Softgesl Carton

FULL PRESCRIBING INFORMATION

Active ingredients (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Nasal decongestant

NON-DROWSY DAYTIME SINUS RELIEF Uses

temporarily relieves sinus symptoms:

• sinus pain
• headache
• nasal & sinus congestion

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.                                                                                                             

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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.   

When using this product, do not use more than directed.

Stop use and ask a doctor if

• redness or swelling is present 
• you get nervous, dizzy or sleepless              
• fever gets worse or lasts more than 3 days
• new symptoms occur       
• symptoms do not get better within 7 days or are accompanied by a fever 

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

Taking more than directed 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 & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed - see Overdose warning
• do not exceed 4 doses per 24 hours

• when taking NIGHTTIME or DAYTIME products, carefully read each label to insure correct dosing

NON-DROWSY DAYTIME SINUS RELIEF Other information

• store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

FD&C Yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions or comments?

Report serious side effects to PuraVation Pharmaceuticals Inc, 1001 Durham Avenue, Suite 300, South Plainfield, NJ 07080

PRINCIPAL DISPLAY PANEL - 20 Softgesl Carton

Sinus Relief DAYTIME

NDC 76270-113-08

*Compare to the active ingredients in VICKS®DAYQUIL®SINEX®

Acetaminophen

Pain Reliever

Phenylephrine

Nasal Decongestant

Relieves:

• Sinus Headache and Pain
• Sinus Congestion and Pressure

Non-Drowsy

SEE NEW WARNINGS INFORMATION

20 softgels