Label: FIRST AID DIRECT NASAL AND SINUS DECONGESTANT- phenylephrine hcl tablet

  • NDC Code(s): 42961-125-01, 42961-125-02
  • Packager: Cintas 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 9, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Phenylephrine HCl 10 mg

  • PURPOSE

    Purpose

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves sinus congestion and pressure
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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 dose

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a 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 (1-800-222-1222) right away. 

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years and over:

    • 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 20°-25°C (68°-77°F)
    • do not use if packet is opened or torn
  • INACTIVE INGREDIENT

    Inactive ingredients

    croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

  • QUESTIONS

    Questions or comments?

    Call 1-800-327-2704 M-F 8AM-5PM

  • Principal Display Panel - 25 CT Box

    NASAL & SINUS DECONGESTANT 

    • Compare to active ingredients in SUDAFED PE® Sinus Congestion*
    • Helps to temporarily relieve: sinus congestion and pressure, nasal congestion due to the common cold, hay fever or other upper respiratory allergies 

    25 Tablets • 1 Tablet per Packet

    NASAL & SINUS DECONGESTANT

    Active Ingredient:

    Phenylephrine HCl 10 mg

    • Compare to active ingredients in SUDAFED PE® Sinus Congestion*
    • Aspirin-free formula

    25 Tablet • 1 Tablet per Packet

    Product #112350

    Label_01

    Label_02

  • INGREDIENTS AND APPEARANCE
    FIRST AID DIRECT NASAL AND SINUS DECONGESTANT 
    phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-125
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-125-0225 in 1 BOX08/09/2023
    1NDC:42961-125-011 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/09/2023
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(42961-125)
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