Label: ULINE SINUS AND CONGESTION- 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 January 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Phenylephrine HCl 5mg

  • PURPOSE

    Purpose

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves

    • nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • sinus congestion and pressure

  • WARNINGS

    Warnings

  • DO NOT USE

    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 DOCTOR

    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 dosage
  • STOP USE

    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
  • 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 right away (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed

    Adults and children: (12 years and older)

    Take 2 tablets every 4 to 6 hours. Do not take more than 12 tablets in 24 hours.

    Children under 12 years:

    Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature 59º-86º F (15º-30º C).
    • tamper evident sealed packets.
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

  • QUESTIONS

    Questions or comments? 1-800-295-5510

  • PRINCIPAL DISPLAY PANEL

    ULINE

    Sinus & Congestion

    Phenylephrine HCl 5mg

    •Nasal Decongestant

    Tamper evident sealed packets:

    Do not use if packet is open or torn.

    Pull to Open

    50 Packets

    2 tablets Each

    205R Uline

  • INGREDIENTS AND APPEARANCE
    ULINE SINUS AND CONGESTION 
    phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69790-161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69790-161-3350 in 1 BOX10/07/2019
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/07/2019
    Labeler - Uline (039612668)
    Registrant - Unifirst First Aid Corporation (832947092)
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