Label: NON-DROWSY NASAL DECONGESTANT PE- phenylephrine hcl 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 October 13, 2020

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  • ACTIVE INGREDIENT

    Phenylephrine HCl 10mg

  • INACTIVE INGREDIENT

    microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, FD&C yellow# 6, FD&C red #40, titanium dioxide, D&C yellow #10

  • DOSAGE & ADMINISTRATION

    * take with a full glass of water

    * swallow whole; do not crush, chew or dissolve

    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

  • INDICATIONS & USAGE

    * temporarily relieves sinus congestion and pressure

    * temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

  • 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
    • diabetes
    • thyroid disease
    • 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • PURPOSE

    Nasal Decongestant

  • PRINCIPAL DISPLAY PANEL

    100

  • INGREDIENTS AND APPEARANCE
    NON-DROWSY NASAL DECONGESTANT PE 
    phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-100
    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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 1000000 (UNII: HZ58M6D839)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code S71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-100-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product02/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/22/2018
    Labeler - Strive Pharmaceuticals Inc. (080028013)
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