Label: DG HEALTH NASAL DECONGESTANT PE MAXIMUM STRENGTH- phenylephrine hydrochloride tablet

  • NDC Code(s): 55910-094-68, 55910-094-89
  • Packager: Dolgencorp, LLC
  • Category: HUMAN OTC DRUG LABEL

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 19, 2018

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  • Active ingredient (in each tablet)

    Phenylephrine hydrochloride 10 mg

  • Purpose

    Nasal decongestant

  • Uses

    •
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    •
    temporarily relieves sinus congestion and pressure
  • 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
    •
    trouble urinating due to an enlarged prostate gland
    •
    diabetes

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    •
    you get nervous, dizzy or sleepless
    •
    symptoms do not improve within 7 days or are accompanied by 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

    do not use this product in children under 12 years of age
  • Other information

    •
    store at 20º-25ºC (68º-77ºF)
  • Inactive ingredients

    anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

  • Questions or comments? 1-888-309-9030

  • Principal Display Panel

    Compare to active ingredient of Sudafed PE®

    Maximum Strength

    Nasal Decongestant PE

    Phenylephrine HCl Tablets, 10 mg

    Non-Drowsy

    Nasal & Sinus Congestion

    Sinus Pressure

    1 Pill/Dose

    SEE NEW DOSING DIRECTIONS

    Nasal Decongestant PE Carton Image 1

    Nasal Decongestant PE Carton Image 1

    Nasal Decongestant PE Carton Image 2

    Nasal Decongestant PE Carton Image 1

    Nasal Decongestant PE Carton Image 2

  • INGREDIENTS AND APPEARANCE
    DG HEALTH NASAL DECONGESTANT PE  MAXIMUM STRENGTH
    phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-094
    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)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code L7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-094-682 in 1 CARTON02/26/2010
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:55910-094-891 in 1 CARTON01/29/2010
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/29/2010
    Labeler - Dolgencorp, LLC (068331990)
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