ASSURED MAXIMUM STRENGTH NASAL DECONGESTANT (PHENYLEPHRINE HCL) TABLET [SPIRIT PHARMACEUTICALS LLC]

ASSURED MAXIMUM STRENGTH NASAL DECONGESTANT (PHENYLEPHRINE HCL) TABLET [SPIRIT PHARMACEUTICALS LLC]
PDF | XML

NDC 68210-1180-2
Set ID 3913362c-30a3-4803-a19b-91b5f7122f2f
Category HUMAN OTC DRUG LABEL
Packager Spirit Pharmaceuticals LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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

    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)

  • SPL UNCLASSIFIED SECTION

    Drug Facts (continued)

  • 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 years ask a doctor

  • Other information

    store between 20° to 25°C (68° to 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

    Questions or comments? 1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    ASSURED 

    COMPARE TO ACTIVE INGREDIENT IN
    SUDAFED® PE CONGESTION®†

    MAXIMUM STRENGTH

    Nasal Decongestant

    · Phenylephrine HCl 10 mg - Nasal Decongestant

    Relieves Nasal & Sinus Congestion,
    Reduces Sinus Pressure, Non-Drowsy

    Actual Size

    PSEUDOEPHEDRINE FREE

    24tablets

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

    image description

  • INGREDIENTS AND APPEARANCE
    ASSURED MAXIMUM STRENGTH NASAL DECONGESTANT 
    phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1180
    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
    ShapeCAPSULESize8mm
    FlavorImprint Code 272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1180-21 in 1 CARTON02/26/2019
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/26/2019
    Labeler - Spirit Pharmaceuticals LLC (179621011)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(68210-1180)

Related Drugs