Label: NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 1, 2025

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  • Active Ingredient (in each tablet)

    Phenylephrine HCl 10mg

  • 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 ifyou 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.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away.

  • 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

    • each tablet contains:phosphorus 10 mg
    • store between 20°-25°C (68°-77°F)
    • protect from excessive moisture
    • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
  • Inactive Ingredients

    Crosscarmellose Soidum, Colloidal Silicon Dioxide, Dicalcium Phosphate, FD&C Red 40, Magnesium Stearate, Microcrystalline Cellulose

  • Questions?

    call toll free 1-844-912-4012

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    BI-MART

    Eugene, OR 97402

  • PRINCIPAL DISPLAY PANEL-36 Count

    NDC 37835-651-36

    Compare to the active ingredients in Sudafed PE® Sinus Congestion*

    NON-DROWSY

    NASAL DECONGESTANT PE

    Phenylephrine HCl 10 mg

    Relieves: Nasal & Sinus Congestion & Sinus Pressure

    36 Tablets

    *This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.

    label

  • PRINCIPAL DISPLAY PANEL-100 Count

    NDC 37835-651-01

    Compare to the active ingredients in Sudafed PE® Sinus Congestion*

    NON-DROWSY

    NASAL DECONGESTANT PE

    Phenylephrine HCl 10 mg

    Relieves: Nasal & Sinus Congestion & Sinus Pressure

    100 Tablets

    *This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.

    label

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT PE 
    phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37835-651
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DICALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code S08
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37835-651-3636 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2025
    2NDC:37835-651-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2025
    Labeler - Bi-Mart (027630078)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(37835-651)
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