Label: CABINET NASAL DECONGESTANT- phenylephrine hydrochloride tablet

  • NDC Code(s): 68210-1290-1, 68210-1290-2
  • Packager: Spirit Pharmaceutical LLC
  • 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 December 9, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Phenylephrine HCl 10 mg

  • Purpose

    Nasal decongestant

  • Uses

    • temporarily relieves sinus congestion and pressure
    • temporarily relieves nasal congestion due to the 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 this product do not exceed recommended dose

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever

    If pregnant or breast-feeding, ask a 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. (1-800-222-1222)

  • Directions

    adults and children 12 years and over
    • take 1 tablet every 4 hours
    • do not take more than 6 tablets in 24 hours
    children under 12 yearsask a doctor
  • Other information

    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    Croscarmellose sodium,FD&C red #40 aluminum
    lake, FD&C yellow #6 aluminum lake, hypromellose,
    lactose, magnesium stearate, microcrystalline
    cellulose, polyethylene glycol, silicon dioxide,
    titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient
    in Sudafed PE® Congestion*

    CABINET:

    Nasal Decongestant

    Phenylephrine HCl 10mg

    50 Tablets

    *This product is not manufactured or distributed by
    McNeil Consumer Healthcare, owner of the
    registered trademark Sudafed PE® Congestion

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  • INGREDIENTS AND APPEARANCE
    CABINET NASAL DECONGESTANT 
    phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1290
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1290-21 in 1 CARTON10/29/2019
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:68210-1290-150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/29/2019
    Labeler - Spirit Pharmaceutical LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(68210-1290)