Label: MEDIQUE MEDI-PHENYL- phenylephrine hydrochloride tablet, film coated
DOVER SUDANYL PE- phenylephrine hydrochloride tablet, film coated

  • NDC Code(s): 47682-161-13, 47682-161-33, 47682-161-99, 47682-162-13, view more
    47682-162-99
  • 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 June 2, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active ingredient (in each tablet)

    Phenylephrine HCl 5mg

    Purpose

    Nasal decongestant

    Uses

    Temporarily relieves

    ■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

    ■ sinus congestion and pressure

    Promotes nasal and/or sinus drainage

    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.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Directions

    • do not use more than directed

    Adults and children: (12 years and older)

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

    Children under 12 years:

    Do not give to children under 12 years of age

    Other information

    • read all product information before using.
    • store at room temperature 59º-86º F (15º-30º C).
    • tamper evident sealed packets.
    • do not use any opened or torn packets

    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 or comments?

    1-800-634-7680

  • 205R Medique Medi-Phenyl Label

    Medique®
    Medi-Phenyl
    Pseudoephedrine Free

    Pull to Open

    Nasal Decongestant • Phenylephrine HCl 5mg

    100 Tablets
    (50 x 2)
    Tamper Evident Unit Dose Packets

    Medique Medi-Phenyl

  • Dover Sudanyl Label

    Dover
    Sudanyl PE
    Nasal and Nasal Decongestant
    Non-Drowsy, Sugar Free
    Phenylephrine HCl 5mg
    Dover Pharmaceutical
    Products of the highest quality and effectiveness
    Tamper Resistant
    Sealed Packets
    Unit Dose Packs
    500 Tablets
    (250 Packets of 2)

    Dover Sudanyl Label 18

  • INGREDIENTS AND APPEARANCE
    MEDIQUE MEDI-PHENYL 
    phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-161
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-161-33100 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-161-13500 in 1 BOX12/30/2008
    2NDC:47682-161-992 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-161-992 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
    DOVER SUDANYL PE 
    phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-162
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    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 (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-162-13500 in 1 BOX12/30/2008
    1NDC:47682-162-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-162-992 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
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging170837962relabel(47682-161, 47682-162) , repack(47682-161, 47682-162)