Daytime Sinus And Congestion
FDA Label NDC 51013-159

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Daytime Sinus And Congestion (NDC 51013-159). 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 active ingredients (in each softgel), purposes, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/Fever reducer

Nasal decongestant

Uses

  • temporarily relieves symptoms due to the common cold
  • minor aches and pains
  • headache
  • fever
  • nasal congestion
  • sinus congestion & pressure
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
  • minor aches and pains
  • headache
  • nasal congestion
  • sinus congestion & pressure

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 for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product


    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

      • If a skin reaction occurs, stop use and seek medical help right away.

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  
  • high blood pressure            
  • thyroid disease
  • diabetes  
  • trouble urinating due to enlarged prostate gland

Stop Use And Ask A Doctor If

  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • you get nervous, dizzy or sleepless

Keep Out Of Reach Of Children.

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 
  • do not exceed 4 doses per 24 hrs

    • 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

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 and white edible ink

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Daytime Sinus & Congestion 24 SOFTGELS

NDC 51013-159-04

Compare to Vicks® QlearQuil® Daytime Sinus & Congestion active ingredients*

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