Multi-Symptom Nighttime Sinus Relief

PuraVation Pharmaceuticals Inc

MULTI-SYMPTOM NIGHTTIME SINUS RELIEF capsule, liquid filled

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each softgel)
• Purpose
• Multi-Symptom Nighttime Sinus Relief Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• Multi-Symptom Nighttime Sinus Relief Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL - 20 Softgels Carton

FULL PRESCRIBING INFORMATION

Active ingredients (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Multi-Symptom Nighttime Sinus Relief Uses

temporarily relieves nasal & sinus symptoms:

• sinus pain 
• headache  
• nasal & sinus congestion 
• runny nose & sneezing

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.   
• to make a child sleep                                                                                                          

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• 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 & tranquilizers may increase drowsiness

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 hrs

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

Multi-Symptom Nighttime Sinus Relief Other information

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

Inactive ingredients

FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

PRINCIPAL DISPLAY PANEL - 20 Softgels Carton

Sinus Relief NIGHTTIME

NDC 76270-114-08

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

Acetaminophen

Pain Reliever

Doxylamine Succinate

Antihistamine

Phenylephrine

Nasal Decongestant

Relieves:

• Sinus Headache and Pain
• Runny Nose
• Sinus Congestion and Pressure

SEE NEW WARNINGS INFORMATION

20 softgels