Label: NASAL DECONGESTANT- phenylephrine hcl tablet

  • NDC Code(s): 68210-4109-2
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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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)

  • 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

    carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrytalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, titanium dioxide
    *contains one or more of these ingredients

  • QUESTIONS

    Questions or comments? 1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO ACTIVE INGREDIENT IN

    SUDAFED® PE CONGESTION®†

    MAXIMUM STRENGTH

    Nasal Decongestant

    · Phenylephrine HCl 10 mg - Nasal Decongestant

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

    image description

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4109
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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 400 (UNII: B697894SGQ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUND (tablet) Size8mm
    FlavorImprint Code 272;S08;T234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4109-2225 in 1 BOTTLE; Type 0: Not a Combination Product09/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/11/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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