Label: XPECT DECONGESTANT- phenylephrine tablet

  • NDC Code(s): 42961-205-01, 42961-205-02
  • Packager: Cintas Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 13, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Phenylephrine HCl 5mg

  • PURPOSE

    Active ingredients (in each tablet):
    Phenylephrine HCl 5mg……………Nasal Decongestant

  • INDICATIONS & USAGE

    Temporarily relieves nasal congestion due to:
    • Common cold, hay fever or other upper respiratory allergies
    • Sinus congestion and pressure helps decongest sinus openings and passages
    • Temporarily restores free breathing through the nose

  • WARNINGS

    Temporarily relieves nasal congestion due to:
    • Common cold, hay fever or other upper respiratory allergies
    • Sinus congestion and pressure helps decongest sinus openings and passages
    • Temporarily restores free breathing through the nose
    3. Warning(s) (c)(5)
    Do not use 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.
    Ask a doctor before use if you have:
    • Heart disease
    • High blood pressure
    • Thyroid disease
    • Diabetes
    • Trouble urinating due to enlarged prostate gland
    When using this product do not exceed recommended dose
    Stop using and ask doctor if:
    • Nervousness, dizziness or sleeplessness occur
    • Symptoms do not improve within 7 days or are accompanied by fever
    • New symptoms occur
    If pregnant or breast-feeding, ask health professional before use.
    Keep out of reach of children
    In case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: Take 2 tablets every 4 hours not to exceed 8 tablets in 24 hours, unless directed by a doctor.
    Children under 12 years of age: Ask a doctor.

  • OTHER SAFETY INFORMATION

    • Do not use if package is torn, cut, or opened
    • Store at room temperature 59-86F (15-30C)
    • Avoid excessive heat and humidity

  • INACTIVE INGREDIENT

    crosscarmellose sodium, D&C Red #27, dicalcium phosphate, Hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, starch, stearic acid

  • PRINCIPAL DISPLAY PANEL

    Xpect Decongestant

  • INGREDIENTS AND APPEARANCE
    XPECT DECONGESTANT 
    phenylephrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-205
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-205-0280 in 1 BOX02/27/2021
    1NDC:42961-205-012 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/27/2021
    Labeler - Cintas Corporation (056481716)