Label: 7 SELECT NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet, film coated

  • 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 September 5, 2019

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

  • 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 this product

    do not exceed recommended dosage

    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 at 20-25°C (68-77°F)
    do not use if blister unit is broken or torn
  • 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?

    1-800-719-9260

  • Principal Display Panel

    Compare to Sudafed PE® Congestion active ingredient

    Non-Drowsy

    Maximum Strength

    Nasal Decongestant PE

    Phenylephrine HCl Tablets, 10 mg

    Nasal & Sinus Congestion

    Sinus Pressure

    18 TABLETS

    10 mg EACH

    Actual Size

    7 Select Nasal Decongestant PE image
  • INGREDIENTS AND APPEARANCE
    7 SELECT NASAL DECONGESTANT PE 
    phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10202-094
    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
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code L7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10202-094-8918 in 1 CARTON10/07/201611/30/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/07/201611/30/2020
    Labeler - 7-Eleven (007347602)