Label: SINUS CONGESTION RELIEF- phenylephrine hydrochloride tablet, coated

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

Drug Label Information

Updated December 20, 2024

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  • 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 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 & children 12 years & over
    • take 1 tablet every 4 hours
    • do not take more than 6 tablets in 24 hours
    children under 12 yearsask a doctor

  • Other information

    • store between 20-25°C (68-77°F)

  • Inactive ingredients

    colloidal silicon dioxide, D&C yellow#10 aluminum lake, FD&C Blue#1, FD&C Red #40, hypromellose, magnesium stearate, microcrytalline cellulose, polyethylene glycol, starch, sodium starch glycolate, talc, titanium dioxide

  • Questions or comments?

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  • PRINCIPAL DISPLAY PANEL

    Compare to active
    ingredient in Sudafed PE®
    Sinus Congestion†

    NDC 82501-1577-1

    Good now

    Sinus Congestion Relief PE
    Phenylephrine HCl Tablets, 10 mg

    24 TABLETS

    Nasal Decongestant

    Relief of
    Nasal & Sinus Congestion
    Sinus Pressure

    Sinus Congestion Carton

  • INGREDIENTS AND APPEARANCE
    SINUS CONGESTION RELIEF 
    phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82501-1577
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code S08
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82501-1577-11 in 1 CARTON05/30/2022
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/30/2022
    Labeler - Gobrands, Inc (057499049)
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