Label: MEDI-FIRST SINUS DECONGESTANT- phenylephrine hydrochloride tablet, film coated
MEDI-FIRST PLUS SINUS DECONGESTANT- phenylephrine hydrochloride tablet, film coated

  • NDC Code(s): 47682-809-13, 47682-809-33, 47682-809-46, 47682-809-48, view more
    47682-809-64, 47682-990-33, 47682-990-48
  • Packager: Unifirst First Aid Corporation
  • 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 August 12, 2021

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

  • Drug Facts

    Active ingredient (in each tablet)

    Phenylephrine HCl 10 mg

  • 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

    • 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

    • you get nervous, dizzy, or sleepless
    • symptoms do not improve within 7 days or are accompanied by fever

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

    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 doses in 24 hours.

    Children under 12 years: Ask a doctor

  • SPL UNCLASSIFIED SECTION

    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

  • Medi-First Sinus Decongestant Label

    100 Tablets

    (100 x 1)

    Medi-First®

    Sinus Decongestant

    Compare active ingredients to:

    Sudafed® PE

    Registered Trademark of Pfizer Consumer

    Nasal Decongestant ● Phenylephrine HCl 10mg

    Tamper Evident Unit Dose Packets

    MF Sinus

  • Medi-First Plus Sinus Decongestant Label

    100 Tablets

    (100 x 1's)

    Medi-First® Plus

    Sinus Decongestant

    Phenylephrine HCl 10mg

    Pull To Open

    Pseudoephedrine Free

    Sinus Relief

    Compare active ingredient to:

    Sudafed PE®

    Registered Trademark of McNeil Consumer Healthcare

    Tamper Evident Unit Dose Packets

    MFP Sinus

  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST SINUS DECONGESTANT 
    phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-809
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-809-6424 in 1 BOX12/30/2008
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-809-33100 in 1 BOX12/30/2008
    21 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-809-48250 in 1 BOX12/30/2008
    31 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-809-13500 in 1 BOX12/30/2008
    4NDC:47682-809-461 in 1 PACKET; Type 0: Not a Combination Product
    5NDC:47682-809-461 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/2008
    MEDI-FIRST PLUS SINUS DECONGESTANT 
    phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-990
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-990-33100 in 1 BOX04/18/2019
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-990-48250 in 1 BOX04/18/2019
    21 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/18/2019
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761relabel(47682-809, 47682-990) , repack(47682-809, 47682-990)