Label: NASAL DECONGESTANT PE- phenylephrine hydrochloride 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 March 18, 2014

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

View All Sections
  • Active ingredient (in each tablet)

    Phenylephrine HCl 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

    • high blood pressure
    • heart disease
    • 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 years: do not use this product for children under 12 years of age
  • Other information

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

    carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminium lake, FD&C yellow #6 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-632-6900

  • Principal Display Panel

    Compare to the active ingredient of SUDAFED PE® NASAL DECONGESTANT *See bottom panel

    NON- DROWSY

    Nasal Decongestant PE

    Phenylephrine HCl Tablets

    Nasal Decongestant

    Does Not Contain Pseudoephedrine

    MAXIMUM STRENGTH

    Relieves:

    • Nasal & Sinus Congestion
    • Sinus Pressure

    1 pill/dose

    TABLETS 10 mg EACH

    GLUTEN FREE

    *Sudafed PE® is a registered trademark of McNeil Consumer Healthcare, Fort Washington, PA 19034. McNeil Consumer Healthcare is not affiliated with The Kroger Co. or this product.

    EACH DOSE INDIVIDUALLY SEALED IN A BLISTER PACK . DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.Phenylephrine HCl 10 mg

    Kroger Nasal Decongestant PE Tablets

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT PE 
    phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-670
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code T234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-670-181 in 1 CARTON
    118 in 1 BLISTER PACK
    2NDC:30142-670-362 in 1 CARTON
    218 in 1 BLISTER PACK
    3NDC:30142-670-724 in 1 CARTON
    318 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/02/2011
    Labeler - The Kroger Co. (006999528)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!