Label: UNISHIELD SINUS DECONGESTANT- phenylephrine hcl tablet, film coated

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

Drug Label Information

Updated November 13, 2024

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  • SPL UNCLASSIFIED SECTION

    DRug Factr

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Phenylephrine HCl 10 mg

  • PURPOSE

    Purpose

    Nasal decongestant

  • INDICATIONS & USAGE

    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 1 tablet every 4 hours. Do not take more than 6 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? 800-480-5855

  • Unishield Sinus Decongestant Label

    Unishield

    Sinus Decongestant

    Phenylephrine HCl 10 mg

    100 Tablets/ 1 Tablet Per Packet

    Pseudoephedrine Free Sinus Relief

    Pull To Open

    • For sinus headache, pain, pressure, and congestion

    Compare active ingredients to:

    Sudafed PE®

    Registered Trademark of McNeil Consumer Healthcare

    Tamper Evident Unit Dose Packets

    208R

  • INGREDIENTS AND APPEARANCE
    UNISHIELD SINUS DECONGESTANT 
    phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-2083
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-2083-3100 in 1 BOX03/01/2021
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2021
    Labeler - Unishield (790677053)
    Registrant - Unifirst First Aid Corporation (832947092)
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