Label: NASAL DECONGESTANT PE- phenylephrine hcl 10 mg tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 17, 2024

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  • Active Ingredient (in each tablet)

    Phenylephrine HCl 10mg

  • Purpose

    Nasal decongestant

  • USES:

    ■ temporarily relieves sinus congestion and pressure

    ■ temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies

  • WARNINGS:

    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 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 

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
  • WHEN USING

    When using this product do not exceed recommended dose.

  • Stope use and ask a doctor if 

    • nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever. 
  • PREGNANCY OR BREAST FEEDING

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

  • 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. (1-800-222-1222).

  • DIRECTIONS:

    • take 1 tablet every 4 hours
    • adults and children 12 years and over: do not take more than 6 tablets in 24 hours
    • children under 12 years: ask a doctor
  • OTHER INFORMATION:

    • store between 20-25 °C (68-77 °F)
    • do not use if seal under cap is broken or missing
  • INACTIVE INGREDIENTS: 

    Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Polyvinyl Alcohol, Polyethylene Glycol, FD& Red #40/Allura Red AC Aluminum Lake, Talc, Titanium Dioxide

  • QUESTIONS OR COMMENTS ? 

    Call 1 (718) 337-8733 or visit: support@nuvicare.com

  • PRINCIPAL DISPLAY PANEL

    PL0209-00 NC Nasal Decongestant-100ct

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT PE 
    phenylephrine hcl 10 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84324-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code S08
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84324-010-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/17/2024
    Labeler - NUVICARE LLC (119257565)
    Registrant - NUVICARE LLC (119257565)
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