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NON-DROWSY DAYTIME SINUS RELIEF (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. PuraVation Pharmaceuticals Inc

Generic: acetaminophen, phenylephrine hydrochloride

NON-DROWSY DAYTIME SINUS RELIEF solution - (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) image

IMPRINT: PC12     SHAPE: capsule
    COLOR: orange

  1. FDA Adverse Reactions

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Active Ingredients (in Each Softgel)


Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose


Pain reliever

Nasal decongestant

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

OTC - ASK DOCTOR/PHARMACIST SECTION


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

OTC - WHEN USING SECTION


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 

OTC - PREGNANCY OR BREAST FEEDING SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

Adults & children 12 yrs & over
  2 softgels with water every 4 hrs

Children 4 to under 12 yrs
  ask a doctor

children under 4 yrs
  do not use
  • when taking NIGHTTIME or DAYTIME products, carefully read each label to insure correct dosing

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

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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