Label: PHYSICIANSCARE SINUS NON-DROWSY- phenylephrine hcl tablet, film coated

  • NDC Code(s): 0924-0133-00, 0924-0133-01, 0924-0133-03
  • Packager: Acme United 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 July 13, 2022

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  • Drug Facts

    Active ingredient (in each tablet)

    Phenylephrine HCl 10mg

  • 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

    Promotes nasal and/or sinus drainage.

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

  • 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: Do not give to children under 12 years of age

  • INFORMATION FOR PATIENTS

    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 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 or comments?

    1-800-835-2263

  • Physicians Care Sinus Label

    980087

    Physicians Care®

    Non-Drowsy Sinus

    Decongestant Clears Sinus Pressure & Congestion

    Pull To Open

    Coated Tablets

    Tamper-Evident Packets of 1 Tablet

    Do not use if packet is open or torn.

    Phenylephrine HCl 10mg

    50 Tabletsts (50 Packets, 1 tablet each)

    208R Simus

  • INGREDIENTS AND APPEARANCE
    PHYSICIANSCARE SINUS  NON-DROWSY
    phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0133
    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)  
    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 2000 (UNII: HAF0412YIT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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:0924-0133-0150 in 1 CARTON01/29/2012
    1NDC:0924-0133-001 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-0133-0310 in 1 CARTON01/29/2012
    2NDC:0924-0133-001 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/29/2012
    Labeler - Acme United Corporation (001180207)
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