Label: CRANE SAFETY SINUS DECONGESTANT- 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 July 8, 2021

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

  • Drug Facts

  • Active ingredient (in each tablet)

    Phenylephrine HCl 10 mg

  • Purpose

    Nasal decongestant

  • Uses

    Temporarily relieves

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

    ■ sinus congestion and pressure

  • 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 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?

    877.506.4291

  • Crane Safety Sinus Decongestant Label

    Sinus Decongestant

    Relieves Sinus Congestion

    CRANE Safety®

    Pull to Open

    Nasal Decongestant

    Phenylephrine HCl 10MG

    100 Tablets

    Tamper Evident

    Sealed Packets

    208R

  • INGREDIENTS AND APPEARANCE
    CRANE SAFETY SINUS DECONGESTANT 
    phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-990(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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-990-33100 in 1 BOX01/17/2020
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/17/2020
    Labeler - Crane Safety LLC (080998015)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761relabel(73408-990) , repack(73408-990)