Label: ASSURED MAXIMUM STRENGTH NASAL DECONGESTANT- phenylephrine hcl tablet

  • 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 26, 2019

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  • 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:68210-0118
    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 T234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0118-31 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Laboratories, Inc037052099manufacture(68210-0118)
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